Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 061529
Company: BELCHER PHARMS
Company: BELCHER PHARMS
| 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 |
|---|---|---|---|---|---|---|---|
| 11/17/1971 | 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 |
|---|---|---|---|---|---|
| 07/09/1997 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 08/08/1986 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/24/1986 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |