Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062981
Company: CHARTWELL RX
Company: CHARTWELL RX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PENICILLIN V POTASSIUM | PENICILLIN V POTASSIUM | EQ 125MG BASE/5ML | FOR SOLUTION;ORAL | Discontinued | None | No | No |
| PENICILLIN V POTASSIUM | PENICILLIN V POTASSIUM | EQ 250MG BASE/5ML | FOR SOLUTION;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 |
|---|---|---|---|---|---|---|---|
| 02/10/1989 | 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 |
|---|---|---|---|---|---|
| 10/31/2025 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/15/1995 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/06/1993 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 12/06/1993 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/06/1994 | SUPPL-1 | Labeling |
Label is not available on this site. |