Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 061502
Company: CHARTWELL RX
Company: CHARTWELL RX
| 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 |
| 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 |
|---|---|---|---|---|---|---|---|
| 11/09/1971 | 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 |
|---|---|---|---|---|---|
| 05/01/2024 | SUPPL-140 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/24/2024 | SUPPL-139 | Labeling-Package Insert |
Label is not available on this site. |
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| 04/24/2024 | SUPPL-138 | Labeling-Package Insert |
Label is not available on this site. |
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| 07/07/2000 | SUPPL-137 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/10/1997 | SUPPL-136 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/27/1996 | SUPPL-135 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/05/1991 | SUPPL-134 | Labeling |
Label is not available on this site. |