FDA Orange Book · active-ingredient family
Ergoloid mesylates
Ergoloid mesylates: 4 brands, 30 generics; first approved May 27, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available — 30 ANDA applications approved.
Brands (NDA)
4
Generics (ANDA)
30
Listed patents
0
Presentations
36
Originator applications
Brand (NDA) products
HYDERGINERLDNOVARTISNDA 017993—2 strengths
HYDERGINERLD
NOVARTISNDA 017993—2 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | ORAL | Discontinued | — |
| 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | ORAL | Discontinued | — |
NOVARTISNDA 0187061983
NOVARTISNDA 0187061983
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 1MG | CAPSULE | ORAL | Discontinued | — |
NOVARTISNDA 018418—
NOVARTISNDA 018418—
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 1MG/ML | SOLUTION | ORAL | Discontinued | — |
NOVARTISNDA 009087—2 strengths
NOVARTISNDA 009087—2 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 1MG | TABLET | SUBLINGUAL | Discontinued | — |
| 0.5MG | TABLET | SUBLINGUAL | Discontinued | — |
Abbreviated applications
Generic (ANDA) products (30)
SUN PHARM INDUSTRIESANDA 0811131991
SUN PHARM INDUSTRIESANDA 0811131991
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 1MG | TABLET | ORAL | Discontinued | — |
SUPERPHARMANDA 0892331986
SUPERPHARMANDA 0892331986
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.5MG | TABLET | SUBLINGUAL | Discontinued | — |
SUPERPHARMANDA 0892341986
SUPERPHARMANDA 0892341986
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 1MG | TABLET | SUBLINGUAL | Discontinued | — |
MUTUAL PHARMANDA 0888911985
MUTUAL PHARMANDA 0888911985
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 1MG | TABLET | ORAL | Discontinued | — |
WATSON LABSANDA 0882071984
WATSON LABSANDA 0882071984
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 1MG | TABLET | ORAL | Discontinued | — |
VANGARDANDA 0880131982
VANGARDANDA 0880131982
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.5MG | TABLET | SUBLINGUAL | Discontinued | — |
VANGARDANDA 0880141982
VANGARDANDA 0880141982
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 1MG | TABLET | SUBLINGUAL | Discontinued | — |
WATSON LABSANDA 0872441982
WATSON LABSANDA 0872441982
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 1MG | TABLET | ORAL | Discontinued | — |
WATSON LABSANDA 0864331982
WATSON LABSANDA 0864331982
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 1MG | TABLET | ORAL | Discontinued | — |
SANDOZANDA 085153—
SANDOZANDA 085153—
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.5MG | TABLET | SUBLINGUAL | Discontinued | — |
SANDOZANDA 087417—
SANDOZANDA 087417—
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 1MG | TABLET | SUBLINGUAL | Discontinued | — |
3MANDA 084868—
3MANDA 084868—
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.5MG | TABLET | SUBLINGUAL | Discontinued | — |
3MANDA 085809—
3MANDA 085809—
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 1MG | TABLET | SUBLINGUAL | Discontinued | — |
BRISTOL MYERS SQUIBBANDA 085020—
BRISTOL MYERS SQUIBBANDA 085020—
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 1MG | TABLET | SUBLINGUAL | Discontinued | — |
KV PHARMANDA 085899—
KV PHARMANDA 085899—
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.5MG | TABLET | SUBLINGUAL | Discontinued | — |
KV PHARMANDA 086265—
KV PHARMANDA 086265—
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.5MG | TABLET | SUBLINGUAL | Discontinued | — |
KV PHARMANDA 085900—
KV PHARMANDA 085900—
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 1MG | TABLET | SUBLINGUAL | Discontinued | — |
KV PHARMANDA 086264—
KV PHARMANDA 086264—
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 1MG | TABLET | SUBLINGUAL | Discontinued | — |
LEDERLEANDA 086984—
LEDERLEANDA 086984—
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.5MG | TABLET | SUBLINGUAL | Discontinued | — |
LEDERLEANDA 086985—
LEDERLEANDA 086985—
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 1MG | TABLET | SUBLINGUAL | Discontinued | — |
SUN PHARM INDUSTRIESANDA 087407—
SUN PHARM INDUSTRIESANDA 087407—
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.5MG | TABLET | SUBLINGUAL | Discontinued | — |
SUN PHARM INDUSTRIESANDA 087552—
SUN PHARM INDUSTRIESANDA 087552—
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 1MG | TABLET | SUBLINGUAL | Discontinued | — |
WATSON LABSANDA 084930—
WATSON LABSANDA 084930—
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.5MG | TABLET | SUBLINGUAL | Discontinued | — |
WATSON LABSANDA 087233—
WATSON LABSANDA 087233—
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.5MG | TABLET | SUBLINGUAL | Discontinued | — |
WATSON LABSANDA 085177—
WATSON LABSANDA 085177—
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 1MG | TABLET | SUBLINGUAL | Discontinued | — |
WATSON LABSANDA 087183—
WATSON LABSANDA 087183—
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 1MG | TABLET | SUBLINGUAL | Discontinued | — |
WATSON LABSANDA 086189—
WATSON LABSANDA 086189—
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.5MG | TABLET | SUBLINGUAL | Discontinued | — |
WATSON LABSANDA 086188—
WATSON LABSANDA 086188—
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 1MG | TABLET | SUBLINGUAL | Discontinued | — |
IVAX PHARMSANDA 087186—
IVAX PHARMSANDA 087186—
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.5MG | TABLET | SUBLINGUAL | Discontinued | — |
IVAX PHARMSANDA 087185—
IVAX PHARMSANDA 087185—
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 1MG | TABLET | SUBLINGUAL | Discontinued | — |
Orange Book patent file
Listed patents
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
FDA approval span
Approval history
First approval
May 27, 1982
44 yr 9 mo ago
Most recent approval
Oct 31, 1991
35 yr 2 mo ago
Approvals span 1982–1991 across 34 FDA applications.
Brand (NDA) 412%
Generic (ANDA) 3088%
Ergoloid mesylates — 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.

