Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 089116
Company: COPLEY PHARM
Company: COPLEY PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BROMPHERIL | DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE | 6MG;120MG | TABLET, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 01/22/1987 | 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 |
|---|---|---|---|---|---|
| 06/17/1999 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/23/1999 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/31/1996 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/10/1992 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/31/1990 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 01/15/1992 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/24/1990 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 07/24/1990 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/24/1990 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/31/1989 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/04/1988 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |