Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 060783
Company: AUROBINDO PHARMA USA
Company: AUROBINDO PHARMA USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TETRACYCLINE HYDROCHLORIDE | TETRACYCLINE HYDROCHLORIDE | 250MG | CAPSULE;ORAL | Discontinued | None | No | No |
| TETRACYCLINE HYDROCHLORIDE | TETRACYCLINE HYDROCHLORIDE | 500MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 07/17/1968 | 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 |
|---|---|---|---|---|---|
| 08/09/2014 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
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| 02/05/1998 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/25/1998 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/30/1995 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/22/1993 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/22/1993 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/11/1992 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 01/31/1990 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/31/1990 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/25/1989 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |