Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 061147
Company: STRIDES PHARMA
Company: STRIDES PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SUMYCIN | TETRACYCLINE HYDROCHLORIDE | 250MG | TABLET;ORAL | Prescription | None | No | No |
| SUMYCIN | TETRACYCLINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Discontinued | None | No | No |
| SUMYCIN | TETRACYCLINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Discontinued | None | No | No |
| SUMYCIN | TETRACYCLINE HYDROCHLORIDE | 500MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 02/10/1971 | 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 |
|---|---|---|---|---|---|
| 05/25/2017 | SUPPL-26 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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| 09/30/2004 | SUPPL-25 | Labeling |
Label is not available on this site. |
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| 11/09/1995 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/30/1994 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/24/1992 | SUPPL-21 | Labeling |
Label is not available on this site. |
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| 07/03/1991 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/23/1991 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/22/1997 | SUPPL-16 | Labeling |
Label is not available on this site. |