Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062882
Company: STRIDES PHARMA
Company: STRIDES PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMPICILLIN TRIHYDRATE | AMPICILLIN/AMPICILLIN TRIHYDRATE | EQ 500MG BASE | 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 |
|---|---|---|---|---|---|---|---|
| 02/25/1988 | 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 |
|---|---|---|---|---|---|
| 09/25/2015 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
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| 09/25/2015 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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| 07/22/1997 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 07/01/1994 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 03/31/1994 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/31/1994 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/31/1994 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/01/1993 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 11/20/1991 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/20/1991 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/20/1991 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |