Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070032
Company: NOVEL LABS INC
Company: NOVEL LABS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SULFAMETHOPRIM-DS | SULFAMETHOXAZOLE; TRIMETHOPRIM | 800MG;160MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 02/15/1985 | 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 |
|---|---|---|---|---|---|
| 12/15/2025 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
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| 12/15/2025 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
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| 09/22/2022 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
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| 09/22/2022 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
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| 05/10/1995 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/11/1994 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 06/19/1989 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 05/09/1988 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 02/01/1988 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/08/1987 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/29/1986 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/29/1986 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/17/1986 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |