Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 089681
Company: WOCKHARDT
Company: WOCKHARDT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BROMFED-DM | BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP;ORAL | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 12/22/1988 | 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 |
|---|---|---|---|---|---|
| 07/29/1999 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 10/08/1998 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 10/20/1995 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/20/1995 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/11/1994 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/13/1994 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/02/1993 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/15/1991 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/27/1989 | SUPPL-2 | Labeling |
Label is not available on this site. |