Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087513
Company: PHARM ASSOC
Company: PHARM ASSOC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | 12.5MG/5ML | ELIXIR;ORAL | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 02/10/1982 | 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 |
|---|---|---|---|---|---|
| 03/17/2020 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
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| 06/10/2009 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 03/20/1996 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 11/21/1990 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 04/12/1990 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 11/12/1991 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/14/1988 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 07/25/1988 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 09/09/1987 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |