Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088896
Company: WOCKHARDT
Company: WOCKHARDT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROMETHAZINE VC W/ CODEINE | CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE | 10MG/5ML;5MG/5ML;6.25MG/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 |
|---|---|---|---|---|---|---|---|
| 01/04/1985 | 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 |
|---|---|---|---|---|---|
| 08/23/1990 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 05/22/1989 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 08/16/1988 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/07/1987 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/07/1987 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/07/1987 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/07/1987 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/07/1987 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/02/1986 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/06/1986 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/06/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |