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
Brand (NDA) products
Originator applications
- HYDERGINERLDNOVARTISNDA 017993—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — 0.5MG TABLET ORAL Discontinued — - NOVARTISNDA 0187061983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG CAPSULE ORAL Discontinued — - NOVARTISNDA 018418—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML SOLUTION ORAL Discontinued — - NOVARTISNDA 009087—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET SUBLINGUAL Discontinued — 0.5MG TABLET SUBLINGUAL Discontinued —
Generic (ANDA) products (30)
Abbreviated applications
- ERGOLOID MESYLATESSUN PHARM INDUSTRIESANDA 0811131991
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - ERGOLOID MESYLATESSUPERPHARMANDA 0892331986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET SUBLINGUAL Discontinued — - ERGOLOID MESYLATESSUPERPHARMANDA 0892341986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET SUBLINGUAL Discontinued — - ERGOLOID MESYLATESMUTUAL PHARMANDA 0888911985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - WATSON LABSANDA 0882071984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - ERGOLOID MESYLATESVANGARDANDA 0880131982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET SUBLINGUAL Discontinued — - ERGOLOID MESYLATESVANGARDANDA 0880141982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET SUBLINGUAL Discontinued — - ERGOLOID MESYLATESWATSON LABSANDA 0872441982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - ERGOLOID MESYLATESWATSON LABSANDA 0864331982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - SANDOZANDA 085153—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET SUBLINGUAL Discontinued — - SANDOZANDA 087417—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET SUBLINGUAL Discontinued — - 3MANDA 084868—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET SUBLINGUAL Discontinued — - 3MANDA 085809—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET SUBLINGUAL Discontinued — - BRISTOL MYERS SQUIBBANDA 085020—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET SUBLINGUAL Discontinued — - ERGOLOID MESYLATESKV PHARMANDA 085899—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET SUBLINGUAL Discontinued — - ERGOLOID MESYLATESKV PHARMANDA 086265—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET SUBLINGUAL Discontinued — - ERGOLOID MESYLATESKV PHARMANDA 085900—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET SUBLINGUAL Discontinued — - ERGOLOID MESYLATESKV PHARMANDA 086264—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET SUBLINGUAL Discontinued — - ERGOLOID MESYLATESLEDERLEANDA 086984—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET SUBLINGUAL Discontinued — - ERGOLOID MESYLATESLEDERLEANDA 086985—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET SUBLINGUAL Discontinued — - ERGOLOID MESYLATESSUN PHARM INDUSTRIESANDA 087407—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET SUBLINGUAL Discontinued — - ERGOLOID MESYLATESSUN PHARM INDUSTRIESANDA 087552—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET SUBLINGUAL Discontinued — - ERGOLOID MESYLATESWATSON LABSANDA 084930—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET SUBLINGUAL Discontinued — - ERGOLOID MESYLATESWATSON LABSANDA 087233—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET SUBLINGUAL Discontinued — - ERGOLOID MESYLATESWATSON LABSANDA 085177—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET SUBLINGUAL Discontinued — - ERGOLOID MESYLATESWATSON LABSANDA 087183—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET SUBLINGUAL Discontinued — - WATSON LABSANDA 086189—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET SUBLINGUAL Discontinued — - WATSON LABSANDA 086188—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET SUBLINGUAL Discontinued — - IVAX PHARMSANDA 087186—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET SUBLINGUAL Discontinued — - IVAX PHARMSANDA 087185—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET SUBLINGUAL Discontinued —
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
45 yr ago
Most recent approval
35 yr 6 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
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- 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.
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