Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085083
Company: WATSON LABS
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | 50MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 06/29/1976 | 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 |
|---|---|---|---|---|---|
| 07/17/1998 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/23/1997 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/02/1991 | SUPPL-33 | Labeling |
Label is not available on this site. |
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| 08/31/1990 | SUPPL-32 | Labeling |
Label is not available on this site. |
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| 12/21/1988 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/21/1988 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/21/1988 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/14/1986 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/03/1986 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/03/1986 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/03/1986 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/16/1983 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/25/1983 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/25/1983 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/25/1983 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/25/1983 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/25/1983 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |