FDA Orange Book · active-ingredient family
Morphine sulfate
Morphine sulfate: 17 brands, 58 generics; first approved Sep 18, 1984; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available — 58 ANDA applications approved.
Earliest patent expiry Aug 12, 2028
Brands (NDA)
17
Generics (ANDA)
58
Listed patents
7
Next patent expiry
Aug 12, 2028
in 2 yr 1 mo
Originator applications
Brand (NDA) products
ARYMO ERRLDZYLANDA 20860320173 strengths
ARYMO ERRLD
ZYLANDA 20860320173 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 15MG | TABLET, EXTENDED RELEASE | ORAL | Discontinued | — |
| 30MG | TABLET, EXTENDED RELEASE | ORAL | Discontinued | — |
| 60MG | TABLET, EXTENDED RELEASE | ORAL | Discontinued | — |
OHEMO LIFENDA 20654420154 strengths
OHEMO LIFENDA 20654420154 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 15MG | TABLET, EXTENDED RELEASE | ORAL | Discontinued | — |
| 30MG | TABLET, EXTENDED RELEASE | ORAL | Discontinued | — |
| 60MG | TABLET, EXTENDED RELEASE | ORAL | Discontinued | — |
| 100MG | TABLET, EXTENDED RELEASE | ORAL | Discontinued | — |
FRESENIUS KABI USANDA 20422320135 strengths
FRESENIUS KABI USANDA 20422320135 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 2MG/ML (2MG/ML) | SOLUTION | INTRAMUSCULAR, INTRAVENOUS | Rx | — |
| 4MG/ML (4MG/ML) | SOLUTION | INTRAMUSCULAR, INTRAVENOUS | Rx | — |
| 5MG/ML (5MG/ML) | SOLUTION | INTRAMUSCULAR, INTRAVENOUS | Discontinued | — |
| 8MG/ML (8MG/ML) | SOLUTION | INTRAMUSCULAR, INTRAVENOUS | Discontinued | — |
| 10MG/ML (10MG/ML) | SOLUTION | INTRAMUSCULAR, INTRAVENOUS | Rx | — |
HOSPIRA INCNDA 20251520116 strengths
HOSPIRA INCNDA 20251520116 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 2MG/ML | INJECTABLE | INJECTION | Rx | AP |
| 4MG/ML | INJECTABLE | INJECTION | Rx | AP |
| 8MG/ML | INJECTABLE | INJECTION | Rx | AP |
| 10MG/ML | INJECTABLE | INJECTION | Rx | AP |
| 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE | INJECTION | Discontinued | — |
| 50MG/ML | INJECTABLE | INJECTION | Rx | — |
HIKMANDA 02219520083 strengths
HIKMANDA 02219520083 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 10MG/5ML | SOLUTION | ORAL | Rx | AA |
| 20MG/5ML | SOLUTION | ORAL | Rx | AA |
| 100MG/5ML | SOLUTION | ORAL | Rx | AA |
HIKMANDA 02220720082 strengths
HIKMANDA 02220720082 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 15MG | TABLET | ORAL | Rx | AB |
| 30MG | TABLET | ORAL | Rx | AB |
KADIANRLDALLERGANNDA 020616200712 strengths
KADIANRLD
ALLERGANNDA 020616200712 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 20MG | CAPSULE, EXTENDED RELEASE | ORAL | Discontinued | — |
| 50MG | CAPSULE, EXTENDED RELEASE | ORAL | Discontinued | — |
| 100MG | CAPSULE, EXTENDED RELEASE | ORAL | Discontinued | — |
| 30MG | CAPSULE, EXTENDED RELEASE | ORAL | Discontinued | — |
| 60MG | CAPSULE, EXTENDED RELEASE | ORAL | Discontinued | — |
| 80MG | CAPSULE, EXTENDED RELEASE | ORAL | Discontinued | — |
| 200MG | CAPSULE, EXTENDED RELEASE | ORAL | Discontinued | — |
| 10MG | CAPSULE, EXTENDED RELEASE | ORAL | Discontinued | — |
| 40MG | CAPSULE, EXTENDED RELEASE | ORAL | Discontinued | — |
| 70MG | CAPSULE, EXTENDED RELEASE | ORAL | Discontinued | — |
| 130MG | CAPSULE, EXTENDED RELEASE | ORAL | Discontinued | — |
| 150MG | CAPSULE, EXTENDED RELEASE | ORAL | Discontinued | — |
ICU MEDICAL INCNDA 01991619922 strengths
ICU MEDICAL INCNDA 01991619922 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE | INJECTION | Discontinued | — |
| 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE | INJECTION | Discontinued | — |
MERIDIAN MEDCL TECHNNDA 0199991990
MERIDIAN MEDCL TECHNNDA 0199991990
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 10MG/0.7ML (10MG/0.7ML) | SOLUTION | INTRAMUSCULAR | Discontinued | — |
MS CONTINRLDKNOA PHARMANDA 01951619895 strengths
MS CONTINRLD
KNOA PHARMANDA 01951619895 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 30MG | TABLET, EXTENDED RELEASE | ORAL | Rx | AB |
| 60MG | TABLET, EXTENDED RELEASE | ORAL | Rx | AB |
| 15MG | TABLET, EXTENDED RELEASE | ORAL | Rx | AB |
| 100MG | TABLET, EXTENDED RELEASE | ORAL | Rx | AB |
| 200MG | TABLET, EXTENDED RELEASE | ORAL | Rx | AB |
HIKMANDA 01856519844 strengths
HIKMANDA 01856519844 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.5MG/ML | INJECTABLE | INJECTION | Rx | AP |
| 1MG/ML | INJECTABLE | INJECTION | Rx | AP |
| 10MG/ML | INJECTABLE | INJECTION | Rx | AP |
| 25MG/ML | INJECTABLE | INJECTION | Rx | AP |
CHARTWELL MOLECULARNDA 2015172011
CHARTWELL MOLECULARNDA 2015172011
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 100MG/5ML | SOLUTION | ORAL | Discontinued | — |
PACIRA PHARMS INCNDA 02167120043 strengths
PACIRA PHARMS INCNDA 02167120043 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 10MG/ML (10MG/ML) | INJECTABLE, LIPOSOMAL | EPIDURAL | Discontinued | — |
| 15MG/1.5ML (10MG/ML) | INJECTABLE, LIPOSOMAL | EPIDURAL | Discontinued | — |
| 20MG/2ML (10MG/ML) | INJECTABLE, LIPOSOMAL | EPIDURAL | Discontinued | — |
KING PHARMS LLCNDA 02126020026 strengths
KING PHARMS LLCNDA 02126020026 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 30MG | CAPSULE, EXTENDED RELEASE | ORAL | Discontinued | — |
| 60MG | CAPSULE, EXTENDED RELEASE | ORAL | Discontinued | — |
| 90MG | CAPSULE, EXTENDED RELEASE | ORAL | Discontinued | — |
| 120MG | CAPSULE, EXTENDED RELEASE | ORAL | Discontinued | — |
| 45MG | CAPSULE, EXTENDED RELEASE | ORAL | Discontinued | — |
| 75MG | CAPSULE, EXTENDED RELEASE | ORAL | Discontinued | — |
SPECGX LLCNDA 02063119962 strengths
SPECGX LLCNDA 02063119962 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 1MG/ML | INJECTABLE | INJECTION | Discontinued | — |
| 2MG/ML | INJECTABLE | INJECTION | Discontinued | — |
XANODYNE PHARMS INCNDA 01997719944 strengths
XANODYNE PHARMS INCNDA 01997719944 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 30MG | TABLET, EXTENDED RELEASE | ORAL | Discontinued | — |
| 60MG | TABLET, EXTENDED RELEASE | ORAL | Discontinued | — |
| 100MG | TABLET, EXTENDED RELEASE | ORAL | Discontinued | — |
| 15MG | TABLET, EXTENDED RELEASE | ORAL | Discontinued | — |
ICU MEDICAL INCNDA 0199171992
ICU MEDICAL INCNDA 0199171992
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.5MG/ML | INJECTABLE | INJECTION | Discontinued | — |
Abbreviated applications
Generic (ANDA) products (58)
PHARM ASSOCANDA 20657320232 strengths
PHARM ASSOCANDA 20657320232 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 100MG/5ML | SOLUTION | ORAL | Rx | AA |
| 10MG/5ML | SOLUTION | ORAL | Rx | AA |
SPECGX LLCANDA 21519420232 strengths
SPECGX LLCANDA 21519420232 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 15MG | TABLET | ORAL | Rx | AB |
| 30MG | TABLET | ORAL | Rx | AB |
HIKMAANDA 21145220235 strengths
HIKMAANDA 21145220235 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 2MG/ML | INJECTABLE | INJECTION | Rx | AP |
| 4MG/ML | INJECTABLE | INJECTION | Rx | AP |
| 8MG/ML | INJECTABLE | INJECTION | Rx | AP |
| 10MG/ML | INJECTABLE | INJECTION | Rx | AP |
| 15MG/ML | INJECTABLE | INJECTION | Rx | — |
INGENUS PHARMS NJANDA 21558420222 strengths
INGENUS PHARMS NJANDA 21558420222 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 15MG | TABLET | ORAL | Discontinued | — |
| 30MG | TABLET | ORAL | Discontinued | — |
DR REDDYS LABS SAANDA 20727020222 strengths
DR REDDYS LABS SAANDA 20727020222 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 15MG | TABLET | ORAL | Discontinued | — |
| 30MG | TABLET | ORAL | Discontinued | — |
ANDA REPOSITORYANDA 20315820216 strengths
ANDA REPOSITORYANDA 20315820216 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 20MG | CAPSULE, EXTENDED RELEASE | ORAL | Discontinued | — |
| 30MG | CAPSULE, EXTENDED RELEASE | ORAL | Discontinued | — |
| 50MG | CAPSULE, EXTENDED RELEASE | ORAL | Discontinued | — |
| 60MG | CAPSULE, EXTENDED RELEASE | ORAL | Discontinued | — |
| 80MG | CAPSULE, EXTENDED RELEASE | ORAL | Discontinued | — |
| 100MG | CAPSULE, EXTENDED RELEASE | ORAL | Discontinued | — |
INTL MEDICATION SYSANDA 2028612021
INTL MEDICATION SYSANDA 2028612021
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 1MG/ML | INJECTABLE | INJECTION | Rx | — |
WINDER LABS LLCANDA 21145420213 strengths
WINDER LABS LLCANDA 21145420213 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 10MG/5ML | SOLUTION | ORAL | Rx | AA |
| 20MG/5ML | SOLUTION | ORAL | Rx | AA |
| 100MG/5ML | SOLUTION | ORAL | Rx | AA |
ALKEM LABS LTDANDA 21245120202 strengths
ALKEM LABS LTDANDA 21245120202 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 15MG | TABLET | ORAL | Rx | AB |
| 30MG | TABLET | ORAL | Rx | AB |
UPSHER SMITH LABSANDA 21061020192 strengths
UPSHER SMITH LABSANDA 21061020192 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 15MG | TABLET | ORAL | Rx | AB |
| 30MG | TABLET | ORAL | Rx | AB |
PIRAMAL CRITICALANDA 20439320182 strengths
PIRAMAL CRITICALANDA 20439320182 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 10MG/ML | INJECTABLE | INJECTION | Rx | AP |
| 25MG/ML | INJECTABLE | INJECTION | Rx | AP |
ANI PHARMSANDA 20550920183 strengths
ANI PHARMSANDA 20550920183 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 10MG/5ML | SOLUTION | ORAL | Discontinued | — |
| 20MG/5ML | SOLUTION | ORAL | Discontinued | — |
| 100MG/5ML | SOLUTION | ORAL | Discontinued | — |
HIKMAANDA 2088092017
HIKMAANDA 2088092017
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 100MG/5ML | SOLUTION | ORAL | Discontinued | — |
RHODES PHARMSANDA 20630820172 strengths
RHODES PHARMSANDA 20630820172 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 10MG/5ML | SOLUTION | ORAL | Discontinued | — |
| 100MG/5ML | SOLUTION | ORAL | Discontinued | — |
DR REDDYS LABS SAANDA 20538620164 strengths
DR REDDYS LABS SAANDA 20538620164 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 15MG | TABLET, EXTENDED RELEASE | ORAL | Discontinued | — |
| 30MG | TABLET, EXTENDED RELEASE | ORAL | Discontinued | — |
| 60MG | TABLET, EXTENDED RELEASE | ORAL | Discontinued | — |
| 100MG | TABLET, EXTENDED RELEASE | ORAL | Discontinued | — |
SUN PHARM INDUSTRIESANDA 20563420165 strengths
SUN PHARM INDUSTRIESANDA 20563420165 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 15MG | TABLET, EXTENDED RELEASE | ORAL | Discontinued | — |
| 30MG | TABLET, EXTENDED RELEASE | ORAL | Discontinued | — |
| 60MG | TABLET, EXTENDED RELEASE | ORAL | Discontinued | — |
| 100MG | TABLET, EXTENDED RELEASE | ORAL | Discontinued | — |
| 200MG | TABLET, EXTENDED RELEASE | ORAL | Discontinued | — |
RHODES PHARMSANDA 2064202016
RHODES PHARMSANDA 2064202016
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 20MG/5ML | SOLUTION | ORAL | Discontinued | — |
EPIC PHARMA LLCANDA 09135720165 strengths
EPIC PHARMA LLCANDA 09135720165 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 15MG | TABLET, EXTENDED RELEASE | ORAL | Discontinued | — |
| 30MG | TABLET, EXTENDED RELEASE | ORAL | Discontinued | — |
| 60MG | TABLET, EXTENDED RELEASE | ORAL | Discontinued | — |
| 100MG | TABLET, EXTENDED RELEASE | ORAL | Discontinued | — |
| 200MG | TABLET, EXTENDED RELEASE | ORAL | Discontinued | — |
TRIS PHARMA INCANDA 2035192016
TRIS PHARMA INCANDA 2035192016
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 20MG/5ML | SOLUTION | ORAL | Discontinued | — |
IMPAX LABS INCANDA 20041120167 strengths
IMPAX LABS INCANDA 20041120167 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 20MG | CAPSULE, EXTENDED RELEASE | ORAL | Discontinued | — |
| 30MG | CAPSULE, EXTENDED RELEASE | ORAL | Discontinued | — |
| 50MG | CAPSULE, EXTENDED RELEASE | ORAL | Discontinued | — |
| 60MG | CAPSULE, EXTENDED RELEASE | ORAL | Discontinued | — |
| 80MG | CAPSULE, EXTENDED RELEASE | ORAL | Discontinued | — |
| 100MG | CAPSULE, EXTENDED RELEASE | ORAL | Discontinued | — |
| 40MG | CAPSULE, EXTENDED RELEASE | ORAL | Discontinued | — |
NOVEL LABS INCANDA 20360220155 strengths
NOVEL LABS INCANDA 20360220155 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 15MG | TABLET, EXTENDED RELEASE | ORAL | Discontinued | — |
| 30MG | TABLET, EXTENDED RELEASE | ORAL | Discontinued | — |
| 60MG | TABLET, EXTENDED RELEASE | ORAL | Discontinued | — |
| 100MG | TABLET, EXTENDED RELEASE | ORAL | Discontinued | — |
| 200MG | TABLET, EXTENDED RELEASE | ORAL | Discontinued | — |
CHARTWELL MOLECULARANDA 2023092015
CHARTWELL MOLECULARANDA 2023092015
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 10MG/5ML | SOLUTION | ORAL | Discontinued | — |
CHARTWELL MOLECULARANDA 2023102015
CHARTWELL MOLECULARANDA 2023102015
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 20MG/5ML | SOLUTION | ORAL | Discontinued | — |
HIKMAANDA 20575820153 strengths
HIKMAANDA 20575820153 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 4MG/ML | INJECTABLE | INJECTION | Rx | AP |
| 8MG/ML | INJECTABLE | INJECTION | Rx | AP |
| 10MG/ML | INJECTABLE | INJECTION | Rx | AP |
TRIS PHARMA INCANDA 20351820152 strengths
TRIS PHARMA INCANDA 20351820152 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 10MG/5ML | SOLUTION | ORAL | Discontinued | — |
| 100MG/5ML | SOLUTION | ORAL | Rx | AA |
ACTAVIS ELIZABETHANDA 20384920155 strengths
ACTAVIS ELIZABETHANDA 20384920155 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 15MG | TABLET, EXTENDED RELEASE | ORAL | Rx | AB |
| 30MG | TABLET, EXTENDED RELEASE | ORAL | Rx | AB |
| 60MG | TABLET, EXTENDED RELEASE | ORAL | Rx | AB |
| 100MG | TABLET, EXTENDED RELEASE | ORAL | Rx | AB |
| 200MG | TABLET, EXTENDED RELEASE | ORAL | Rx | AB |
TEVA PHARMS USAANDA 20271820148 strengths
TEVA PHARMS USAANDA 20271820148 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 20MG | CAPSULE, EXTENDED RELEASE | ORAL | Discontinued | — |
| 30MG | CAPSULE, EXTENDED RELEASE | ORAL | Discontinued | — |
| 50MG | CAPSULE, EXTENDED RELEASE | ORAL | Discontinued | — |
| 60MG | CAPSULE, EXTENDED RELEASE | ORAL | Discontinued | — |
| 80MG | CAPSULE, EXTENDED RELEASE | ORAL | Discontinued | — |
| 100MG | CAPSULE, EXTENDED RELEASE | ORAL | Discontinued | — |
| 40MG | CAPSULE, EXTENDED RELEASE | ORAL | Discontinued | — |
| 70MG | CAPSULE, EXTENDED RELEASE | ORAL | Discontinued | — |
SANKALP LIFECAREANDA 20101120143 strengths
SANKALP LIFECAREANDA 20101120143 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 10MG/5ML | SOLUTION | ORAL | Discontinued | — |
| 20MG/5ML | SOLUTION | ORAL | Discontinued | — |
| 100MG/5ML | SOLUTION | ORAL | Discontinued | — |
UPSHER SMITH LABSANDA 20210420137 strengths
UPSHER SMITH LABSANDA 20210420137 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 10MG | CAPSULE, EXTENDED RELEASE | ORAL | Rx | — |
| 20MG | CAPSULE, EXTENDED RELEASE | ORAL | Rx | — |
| 30MG | CAPSULE, EXTENDED RELEASE | ORAL | Rx | — |
| 50MG | CAPSULE, EXTENDED RELEASE | ORAL | Rx | — |
| 60MG | CAPSULE, EXTENDED RELEASE | ORAL | Rx | — |
| 80MG | CAPSULE, EXTENDED RELEASE | ORAL | Rx | — |
| 100MG | CAPSULE, EXTENDED RELEASE | ORAL | Rx | — |
ACTAVIS ELIZABETHANDA 07904020136 strengths
ACTAVIS ELIZABETHANDA 07904020136 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 30MG | CAPSULE, EXTENDED RELEASE | ORAL | Rx | — |
| 45MG | CAPSULE, EXTENDED RELEASE | ORAL | Rx | — |
| 60MG | CAPSULE, EXTENDED RELEASE | ORAL | Rx | — |
| 75MG | CAPSULE, EXTENDED RELEASE | ORAL | Rx | — |
| 90MG | CAPSULE, EXTENDED RELEASE | ORAL | Rx | — |
| 120MG | CAPSULE, EXTENDED RELEASE | ORAL | Rx | — |
PADAGIS USANDA 2015742012
PADAGIS USANDA 2015742012
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 100MG/5ML | SOLUTION | ORAL | Discontinued | — |
SUN PHARM INDS LTDANDA 07876120125 strengths
SUN PHARM INDS LTDANDA 07876120125 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 15MG | TABLET, EXTENDED RELEASE | ORAL | Rx | AB |
| 30MG | TABLET, EXTENDED RELEASE | ORAL | Rx | AB |
| 60MG | TABLET, EXTENDED RELEASE | ORAL | Rx | AB |
| 100MG | TABLET, EXTENDED RELEASE | ORAL | Rx | AB |
| 200MG | TABLET, EXTENDED RELEASE | ORAL | Rx | AB |
VISTAPHARMANDA 20194720122 strengths
VISTAPHARMANDA 20194720122 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 10MG/5ML | SOLUTION | ORAL | Discontinued | — |
| 20MG/5ML | SOLUTION | ORAL | Discontinued | — |
STRIDES PHARMA INTLANDA 20081220116 strengths
STRIDES PHARMA INTLANDA 20081220116 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 20MG | CAPSULE, EXTENDED RELEASE | ORAL | Discontinued | — |
| 30MG | CAPSULE, EXTENDED RELEASE | ORAL | Discontinued | — |
| 50MG | CAPSULE, EXTENDED RELEASE | ORAL | Discontinued | — |
| 60MG | CAPSULE, EXTENDED RELEASE | ORAL | Discontinued | — |
| 80MG | CAPSULE, EXTENDED RELEASE | ORAL | Discontinued | — |
| 100MG | CAPSULE, EXTENDED RELEASE | ORAL | Discontinued | — |
RISINGANDA 20082420115 strengths
RISINGANDA 20082420115 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 15MG | TABLET, EXTENDED RELEASE | ORAL | Discontinued | — |
| 30MG | TABLET, EXTENDED RELEASE | ORAL | Discontinued | — |
| 60MG | TABLET, EXTENDED RELEASE | ORAL | Discontinued | — |
| 100MG | TABLET, EXTENDED RELEASE | ORAL | Discontinued | — |
| 200MG | TABLET, EXTENDED RELEASE | ORAL | Discontinued | — |
SPECGX LLCANDA 2023482011
SPECGX LLCANDA 2023482011
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 100MG/5ML | SOLUTION | ORAL | Rx | AA |
NESHER PHARMSANDA 07785520072 strengths
NESHER PHARMSANDA 07785520072 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 100MG | TABLET, EXTENDED RELEASE | ORAL | Discontinued | — |
| 200MG | TABLET, EXTENDED RELEASE | ORAL | Discontinued | — |
NESHER PHARMSANDA 07672020052 strengths
NESHER PHARMSANDA 07672020052 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 60MG | TABLET, EXTENDED RELEASE | ORAL | Discontinued | — |
| 30MG | TABLET, EXTENDED RELEASE | ORAL | Discontinued | — |
NESHER PHARMSANDA 0767332004
NESHER PHARMSANDA 0767332004
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 15MG | TABLET, EXTENDED RELEASE | ORAL | Discontinued | — |
SPECGX LLCANDA 07641220033 strengths
SPECGX LLCANDA 07641220033 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 15MG | TABLET, EXTENDED RELEASE | ORAL | Rx | AB |
| 30MG | TABLET, EXTENDED RELEASE | ORAL | Rx | AB |
| 60MG | TABLET, EXTENDED RELEASE | ORAL | Rx | AB |
SPECGX LLCANDA 07643820032 strengths
SPECGX LLCANDA 07643820032 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 100MG | TABLET, EXTENDED RELEASE | ORAL | Rx | AB |
| 200MG | TABLET, EXTENDED RELEASE | ORAL | Rx | AB |
WATSON LABSANDA 0756562001
WATSON LABSANDA 0756562001
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 100MG | TABLET, EXTENDED RELEASE | ORAL | Discontinued | — |
DAVA PHARMS INCANDA 0754072000
DAVA PHARMS INCANDA 0754072000
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 15MG | TABLET, EXTENDED RELEASE | ORAL | Rx | AB |
STRIDES PHARMA INTLANDA 07529519985 strengths
STRIDES PHARMA INTLANDA 07529519985 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 15MG | TABLET, EXTENDED RELEASE | ORAL | Discontinued | — |
| 30MG | TABLET, EXTENDED RELEASE | ORAL | Discontinued | — |
| 60MG | TABLET, EXTENDED RELEASE | ORAL | Discontinued | — |
| 100MG | TABLET, EXTENDED RELEASE | ORAL | Discontinued | — |
| 200MG | TABLET, EXTENDED RELEASE | ORAL | Discontinued | — |
RHODES PHARMSANDA 07486219983 strengths
RHODES PHARMSANDA 07486219983 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 15MG | TABLET, EXTENDED RELEASE | ORAL | Rx | AB |
| 30MG | TABLET, EXTENDED RELEASE | ORAL | Rx | AB |
| 60MG | TABLET, EXTENDED RELEASE | ORAL | Rx | AB |
RHODES PHARMSANDA 07476919982 strengths
RHODES PHARMSANDA 07476919982 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 100MG | TABLET, EXTENDED RELEASE | ORAL | Rx | AB |
| 200MG | TABLET, EXTENDED RELEASE | ORAL | Rx | AB |
HOSPIRAANDA 0735091992
HOSPIRAANDA 0735091992
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.5MG/ML | INJECTABLE | INJECTION | Rx | AP |
HOSPIRAANDA 0735101992
HOSPIRAANDA 0735101992
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 1MG/ML | INJECTABLE | INJECTION | Rx | AP |
WATSON LABSANDA 0733731991
WATSON LABSANDA 0733731991
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.5MG/ML | INJECTABLE | INJECTION | Discontinued | — |
WATSON LABSANDA 0733751991
WATSON LABSANDA 0733751991
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.5MG/ML | INJECTABLE | INJECTION | Discontinued | — |
WATSON LABSANDA 0733741991
WATSON LABSANDA 0733741991
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 1MG/ML | INJECTABLE | INJECTION | Discontinued | — |
WATSON LABSANDA 0733761991
WATSON LABSANDA 0733761991
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 1MG/ML | INJECTABLE | INJECTION | Discontinued | — |
HOSPIRAANDA 0718491988
HOSPIRAANDA 0718491988
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.5MG/ML | INJECTABLE | INJECTION | Discontinued | — |
HOSPIRAANDA 0718501988
HOSPIRAANDA 0718501988
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 1MG/ML | INJECTABLE | INJECTION | Discontinued | — |
FRESENIUS KABI USAANDA 0710501986
FRESENIUS KABI USAANDA 0710501986
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.5MG/ML | INJECTABLE | INJECTION | Discontinued | — |
FRESENIUS KABI USAANDA 0710511986
FRESENIUS KABI USAANDA 0710511986
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.5MG/ML | INJECTABLE | INJECTION | Discontinued | — |
FRESENIUS KABI USAANDA 0710521986
FRESENIUS KABI USAANDA 0710521986
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 1MG/ML | INJECTABLE | INJECTION | Discontinued | — |
FRESENIUS KABI USAANDA 0710531986
FRESENIUS KABI USAANDA 0710531986
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 1MG/ML | INJECTABLE | INJECTION | Discontinued | — |
Protection horizon
Patent & exclusivity timeline
Patent expiryExclusivity endToday
Orange Book patent file
Listed patents
Listed patents (7)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10314788 | Aug 12, 2028 | in 2 yr 1 mo | Product |
| 7955619 | Aug 12, 2028 | in 2 yr 1 mo | Product |
| 9549899 | Jul 01, 2033 | in 7 yr 1 mo | ProductU-1556 |
| 9044402 | Jul 01, 2033 | in 7 yr 1 mo | ProductU-1556 |
| 9192608 | Mar 12, 2034 | in 7 yr 9 mo | U-43 |
| 9248229 | Mar 12, 2034 | in 7 yr 9 mo | Product |
| 9072781 | Mar 12, 2034 | in 7 yr 9 mo | Product |
FDA approval span
Approval history
First approval
Sep 18, 1984
42 yr 5 mo ago
Most recent approval
Sep 12, 2023
2 yr 10 mo ago
Approvals span 1984–2023 across 75 FDA applications.
Brand (NDA) 1723%
Generic (ANDA) 5877%
Morphine sulfate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
