Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088833
Company: WOCKHARDT
Company: WOCKHARDT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRIPROLIDINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE AND CODEINE PHOSPHATE | CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE | 10MG/5ML;30MG/5ML;1.25MG/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 |
|---|---|---|---|---|---|---|---|
| 11/16/1984 | 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 |
|---|---|---|---|---|---|
| 12/01/1998 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 11/20/1990 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 05/24/1990 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 01/22/1990 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 02/13/1989 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/14/1987 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/14/1987 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/10/1987 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/10/1987 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/30/1986 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/18/1986 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/24/1985 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/13/1984 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/13/1984 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/13/1984 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/13/1984 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/13/1984 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |