FDA Orange Book · active-ingredient family
Morphine sulfate
Morphine sulfate: 17 brands, 59 generics; first approved Sep 18, 1984; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 59 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
17
Generics (ANDA)
59
Listed patents
7
Next patent expiry
Aug 12, 2028
in 2 yr 1 mo
Brand (NDA) products
Originator applications
- ARYMO ERRLDZYLANDA 20860320173 strengths
Approved strengths under this FDA application. 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
Approved strengths under this FDA application. 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 — - MORPHINE SULFATERLDRSFRESENIUS KABI USANDA 20422320135 strengths
Approved strengths under this FDA application. 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 — - MORPHINE SULFATERLDRSHOSPIRA INCNDA 20251520116 strengths
Approved strengths under this FDA application. 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 Discontinued — 50MG/ML INJECTABLE INJECTION Rx — - MORPHINE SULFATERLDHIKMANDA 02219520083 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/5ML SOLUTION ORAL Rx AA 20MG/5ML SOLUTION ORAL Rx AA 100MG/5ML SOLUTION ORAL Rx AA - MORPHINE SULFATERLDHIKMANDA 02220720082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB - KADIANRLDALLERGANNDA 020616200712 strengths
Approved strengths under this FDA application. 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 — - MORPHINE SULFATERLDICU MEDICAL INCNDA 01991619922 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Discontinued — 5MG/ML INJECTABLE INJECTION Discontinued — - MERIDIAN MEDCL TECHNNDA 0199991990
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/0.7ML (10MG/0.7ML) SOLUTION INTRAMUSCULAR Discontinued — - MS CONTINRLDKNOA PHARMANDA 01951619895 strengths
Approved strengths under this FDA application. 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
Approved strengths under this FDA application. 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 - MORPHINE SULFATECHARTWELL MOLECULARNDA 2015172011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/5ML SOLUTION ORAL Discontinued — - PACIRA PHARMS INCNDA 02167120043 strengths
Approved strengths under this FDA application. 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
Approved strengths under this FDA application. 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 — - MORPHINE SULFATESPECGX LLCNDA 02063119962 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Discontinued — 2MG/ML INJECTABLE INJECTION Discontinued — - XANODYNE PHARMS INCNDA 01997719944 strengths
Approved strengths under this FDA application. 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 — - MORPHINE SULFATEICU MEDICAL INCNDA 0199171992
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG/ML INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (59)
Abbreviated applications
- MORPHINE SULFATEQUAGENANDA 21389220263 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/5ML SOLUTION ORAL Rx AA 20MG/5ML SOLUTION ORAL Rx AA 100MG/5ML SOLUTION ORAL Rx AA - MORPHINE SULFATEPHARM ASSOCANDA 20657320232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/5ML SOLUTION ORAL Rx AA 10MG/5ML SOLUTION ORAL Rx AA - MORPHINE SULFATESPECGX LLCANDA 21519420232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB - MORPHINE SULFATEHIKMAANDA 21145220235 strengths
Approved strengths under this FDA application. 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 — - MORPHINE SULFATEINGENUS PHARMS NJANDA 21558420222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET ORAL Discontinued — 30MG TABLET ORAL Discontinued — - MORPHINE SULFATEDR REDDYS LABS SAANDA 20727020222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET ORAL Discontinued — 30MG TABLET ORAL Discontinued — - MORPHINE SULFATEANDA REPOSITORYANDA 20315820216 strengths
Approved strengths under this FDA application. 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 — - MORPHINE SULFATEINTL MEDICATION SYSANDA 2028612021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx — - MORPHINE SULFATEWINDER LABS LLCANDA 21145420213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/5ML SOLUTION ORAL Rx AA 20MG/5ML SOLUTION ORAL Rx AA 100MG/5ML SOLUTION ORAL Rx AA - MORPHINE SULFATEALKEM LABS LTDANDA 21245120202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB - MORPHINE SULFATEUPSHER SMITH LABSANDA 21061020192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB - PIRAMAL CRITICALANDA 20439320182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Rx AP 25MG/ML INJECTABLE INJECTION Rx AP - MORPHINE SULFATEANI PHARMSANDA 20550920183 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/5ML SOLUTION ORAL Discontinued — 20MG/5ML SOLUTION ORAL Discontinued — 100MG/5ML SOLUTION ORAL Discontinued — - MORPHINE SULFATEHIKMAANDA 2088092017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/5ML SOLUTION ORAL Discontinued — - MORPHINE SULFATERHODES PHARMSANDA 20630820172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/5ML SOLUTION ORAL Discontinued — 100MG/5ML SOLUTION ORAL Discontinued — - MORPHINE SULFATEDR REDDYS LABS SAANDA 20538620164 strengths
Approved strengths under this FDA application. 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 — - MORPHINE SULFATESUN PHARM INDUSTRIESANDA 20563420165 strengths
Approved strengths under this FDA application. 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 — - MORPHINE SULFATERHODES PHARMSANDA 2064202016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/5ML SOLUTION ORAL Discontinued — - MORPHINE SULFATEEPIC PHARMA LLCANDA 09135720165 strengths
Approved strengths under this FDA application. 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 — - MORPHINE SULFATETRIS PHARMA INCANDA 2035192016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/5ML SOLUTION ORAL Discontinued — - MORPHINE SULFATEIMPAX LABS INCANDA 20041120167 strengths
Approved strengths under this FDA application. 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 — - MORPHINE SULFATENOVEL LABS INCANDA 20360220155 strengths
Approved strengths under this FDA application. 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 — - MORPHINE SULFATECHARTWELL MOLECULARANDA 2023092015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/5ML SOLUTION ORAL Discontinued — - MORPHINE SULFATECHARTWELL MOLECULARANDA 2023102015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/5ML SOLUTION ORAL Discontinued — - MORPHINE SULFATERSHIKMAANDA 20575820153 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG/ML INJECTABLE INJECTION Rx AP 8MG/ML INJECTABLE INJECTION Rx AP 10MG/ML INJECTABLE INJECTION Rx AP - MORPHINE SULFATETRIS PHARMA INCANDA 20351820152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/5ML SOLUTION ORAL Discontinued — 100MG/5ML SOLUTION ORAL Rx AA - MORPHINE SULFATEACTAVIS ELIZABETHANDA 20384920155 strengths
Approved strengths under this FDA application. 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 - MORPHINE SULFATETEVA PHARMS USAANDA 20271820148 strengths
Approved strengths under this FDA application. 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 — - MORPHINE SULFATESANKALP LIFECAREANDA 20101120143 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/5ML SOLUTION ORAL Discontinued — 20MG/5ML SOLUTION ORAL Discontinued — 100MG/5ML SOLUTION ORAL Discontinued — - MORPHINE SULFATEUPSHER SMITH LABSANDA 20210420137 strengths
Approved strengths under this FDA application. 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 — - MORPHINE SULFATEACTAVIS ELIZABETHANDA 07904020136 strengths
Approved strengths under this FDA application. 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 — - MORPHINE SULFATEPADAGIS USANDA 2015742012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/5ML SOLUTION ORAL Discontinued — - MORPHINE SULFATESUN PHARM INDS LTDANDA 07876120125 strengths
Approved strengths under this FDA application. 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 - MORPHINE SULFATEVISTAPHARMANDA 20194720122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/5ML SOLUTION ORAL Discontinued — 20MG/5ML SOLUTION ORAL Discontinued — - MORPHINE SULFATESTRIDES PHARMA INTLANDA 20081220116 strengths
Approved strengths under this FDA application. 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 — - MORPHINE SULFATERISINGANDA 20082420115 strengths
Approved strengths under this FDA application. 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 — - MORPHINE SULFATESPECGX LLCANDA 2023482011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/5ML SOLUTION ORAL Rx AA - MORPHINE SULFATENESHER PHARMSANDA 07785520072 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, EXTENDED RELEASE ORAL Discontinued — 200MG TABLET, EXTENDED RELEASE ORAL Discontinued — - MORPHINE SULFATENESHER PHARMSANDA 07672020052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG TABLET, EXTENDED RELEASE ORAL Discontinued — 30MG TABLET, EXTENDED RELEASE ORAL Discontinued — - MORPHINE SULFATENESHER PHARMSANDA 0767332004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET, EXTENDED RELEASE ORAL Discontinued — - MORPHINE SULFATESPECGX LLCANDA 07641220033 strengths
Approved strengths under this FDA application. 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 - MORPHINE SULFATESPECGX LLCANDA 07643820032 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, EXTENDED RELEASE ORAL Rx AB 200MG TABLET, EXTENDED RELEASE ORAL Rx AB - MORPHINE SULFATEWATSON LABSANDA 0756562001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, EXTENDED RELEASE ORAL Discontinued — - MORPHINE SULFATEDAVA PHARMS INCANDA 0754072000
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET, EXTENDED RELEASE ORAL Rx AB - MORPHINE SULFATESTRIDES PHARMA INTLANDA 07529519985 strengths
Approved strengths under this FDA application. 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 — - MORPHINE SULFATERHODES PHARMSANDA 07486219983 strengths
Approved strengths under this FDA application. 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 - MORPHINE SULFATERHODES PHARMSANDA 07476919982 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, EXTENDED RELEASE ORAL Rx AB 200MG TABLET, EXTENDED RELEASE ORAL Rx AB - MORPHINE SULFATEHOSPIRAANDA 0735091992
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG/ML INJECTABLE INJECTION Rx AP - MORPHINE SULFATEHOSPIRAANDA 0735101992
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx AP - MORPHINE SULFATEWATSON LABSANDA 0733731991
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG/ML INJECTABLE INJECTION Discontinued — - MORPHINE SULFATEWATSON LABSANDA 0733751991
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG/ML INJECTABLE INJECTION Discontinued — - MORPHINE SULFATEWATSON LABSANDA 0733741991
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Discontinued — - MORPHINE SULFATEWATSON LABSANDA 0733761991
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Discontinued — - MORPHINE SULFATEHOSPIRAANDA 0718491988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG/ML INJECTABLE INJECTION Discontinued — - MORPHINE SULFATEHOSPIRAANDA 0718501988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Discontinued — - FRESENIUS KABI USAANDA 0710501986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG/ML INJECTABLE INJECTION Discontinued — - FRESENIUS KABI USAANDA 0710511986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG/ML INJECTABLE INJECTION Discontinued — - FRESENIUS KABI USAANDA 0710521986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Discontinued — - FRESENIUS KABI USAANDA 0710531986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 10314788 | in 2 yr 1 mo | Product | |
| 7955619 | in 2 yr 1 mo | Product | |
| 9549899 | in 7 yr | ProductU-1556 | |
| 9044402 | in 7 yr | ProductU-1556 | |
| 9192608 | in 7 yr 9 mo | U-43 | |
| 9248229 | in 7 yr 9 mo | Product | |
| 9072781 | in 7 yr 9 mo | Product |
Approval history
FDA approval span
First approval
42 yr 6 mo ago
Most recent approval
28 d ago
Approvals span 1984–2026 across 76 FDA applications.
Brand (NDA) 1722%
Generic (ANDA) 5978%
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 BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
