Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088577
Company: BARR
Company: BARR
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 500MG;5MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 12/21/1984 | 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 |
|---|---|---|---|---|---|
| 10/02/1989 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 12/20/1988 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 01/19/1990 | SUPPL-21 | Labeling |
Label is not available on this site. |
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| 01/19/1990 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 05/18/1988 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 03/17/1988 | SUPPL-16 | Labeling |
Label is not available on this site. |