Drugs@FDA: FDA-Approved Drugs
Company: ANIMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRIACIN-C | CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE | 10MG/5ML;30MG/5ML;1.25MG/5ML | SYRUP;ORAL | Prescription | None | No | 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 |
|---|---|---|---|---|---|---|---|
| 03/22/1985 | 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 |
|---|---|---|---|---|---|
| 12/15/2023 | SUPPL-39 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/28/2018 | SUPPL-38 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/29/2017 | SUPPL-37 | Labeling-Package Insert |
Label is not available on this site. |
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| 03/15/2017 | SUPPL-36 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 03/15/2017 | SUPPL-35 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/13/2017 | SUPPL-34 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 07/08/2015 | SUPPL-33 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/02/2000 | SUPPL-21 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/19/1998 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/31/1995 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/06/1994 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/08/1992 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 09/11/1992 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 09/28/1990 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/05/1992 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/01/1990 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 06/07/1989 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/07/1989 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/17/1987 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/11/1986 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/11/1986 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/06/1985 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/06/1985 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |