Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 084772
Company: ALPHARMA US PHARMS
Company: ALPHARMA US PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROMETH FORTIS | PROMETHAZINE HYDROCHLORIDE | 25MG/5ML | SYRUP;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 |
|---|---|---|---|---|---|---|---|
| 11/14/1978 | 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 |
|---|---|---|---|---|---|
| 04/18/1990 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 11/28/1989 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 09/27/1988 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 06/06/1988 | SUPPL-15 | Labeling |
Label is not available on this site. |