Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087677
Company: ASCHER
Company: ASCHER
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HY-PHEN | 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 |
|---|---|---|---|---|---|---|---|
| 05/03/1982 | 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 |
|---|---|---|---|---|---|
| 03/09/1995 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 10/14/1993 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 10/27/1992 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/29/1986 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/01/1983 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |