Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062883
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 250MG 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 |
|---|---|---|---|---|---|
| 05/01/2024 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/22/2019 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/22/1997 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 07/01/1994 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 03/31/1994 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/31/1994 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/31/1994 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/01/1993 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 11/20/1991 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/20/1991 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |