Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062270
Company: GLAXOSMITHKLINE
Company: GLAXOSMITHKLINE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BEEPEN-VK | PENICILLIN V POTASSIUM | EQ 125MG BASE/5ML | FOR SOLUTION;ORAL | Discontinued | None | No | No |
| BEEPEN-VK | 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 |
|---|---|---|---|---|---|---|---|
| 08/15/1980 | 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 |
|---|---|---|---|---|---|
| 04/20/1998 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/06/1996 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 05/08/1995 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 02/22/1991 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/06/1989 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |