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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

NDA 0179932 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLETORALDiscontinued
0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLETORALDiscontinued
NDA 0187061983
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
1MGCAPSULEORALDiscontinued
NDA 018418
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
1MG/MLSOLUTIONORALDiscontinued
NDA 0090872 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
1MGTABLETSUBLINGUALDiscontinued
0.5MGTABLETSUBLINGUALDiscontinued
Abbreviated applications

Generic (ANDA) products (30)

ANDA 0811131991
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
1MGTABLETORALDiscontinued
ANDA 0892331986
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
0.5MGTABLETSUBLINGUALDiscontinued
ANDA 0892341986
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
1MGTABLETSUBLINGUALDiscontinued
ANDA 0888911985
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
1MGTABLETORALDiscontinued
ANDA 0882071984
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
1MGTABLETORALDiscontinued
ANDA 0880131982
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
0.5MGTABLETSUBLINGUALDiscontinued
ANDA 0880141982
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
1MGTABLETSUBLINGUALDiscontinued
ANDA 0872441982
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
1MGTABLETORALDiscontinued
ANDA 0864331982
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
1MGTABLETORALDiscontinued
ANDA 085153
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
0.5MGTABLETSUBLINGUALDiscontinued
ANDA 087417
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
1MGTABLETSUBLINGUALDiscontinued
ANDA 084868
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
0.5MGTABLETSUBLINGUALDiscontinued
ANDA 085809
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
1MGTABLETSUBLINGUALDiscontinued
ANDA 085020
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
1MGTABLETSUBLINGUALDiscontinued
ANDA 085899
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
0.5MGTABLETSUBLINGUALDiscontinued
ANDA 086265
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
0.5MGTABLETSUBLINGUALDiscontinued
ANDA 085900
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
1MGTABLETSUBLINGUALDiscontinued
ANDA 086264
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
1MGTABLETSUBLINGUALDiscontinued
ANDA 086984
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
0.5MGTABLETSUBLINGUALDiscontinued
ANDA 086985
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
1MGTABLETSUBLINGUALDiscontinued
ANDA 087407
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
0.5MGTABLETSUBLINGUALDiscontinued
ANDA 087552
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
1MGTABLETSUBLINGUALDiscontinued
ANDA 084930
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
0.5MGTABLETSUBLINGUALDiscontinued
ANDA 087233
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
0.5MGTABLETSUBLINGUALDiscontinued
ANDA 085177
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
1MGTABLETSUBLINGUALDiscontinued
ANDA 087183
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
1MGTABLETSUBLINGUALDiscontinued
ANDA 086189
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
0.5MGTABLETSUBLINGUALDiscontinued
ANDA 086188
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
1MGTABLETSUBLINGUALDiscontinued
ANDA 087186
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
0.5MGTABLETSUBLINGUALDiscontinued
ANDA 087185
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
1MGTABLETSUBLINGUALDiscontinued
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

Agent CTA Background

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