Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078899
Company: ZYDUS PHARMS USA INC
Company: ZYDUS PHARMS USA INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BROMOCRIPTINE MESYLATE | BROMOCRIPTINE MESYLATE | EQ 5MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
07/30/2008 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/27/2022 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
01/19/2021 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
08/13/2012 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
BROMOCRIPTINE MESYLATE
CAPSULE;ORAL; EQ 5MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BROMOCRIPTINE MESYLATE | BROMOCRIPTINE MESYLATE | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 077226 | MYLAN |
BROMOCRIPTINE MESYLATE | BROMOCRIPTINE MESYLATE | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 078899 | ZYDUS PHARMS USA INC |
PARLODEL | BROMOCRIPTINE MESYLATE | EQ 5MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 017962 | SS PHARMA |