Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 061394
Company: APOTHECON
Company: APOTHECON
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PRINCIPEN | AMPICILLIN/AMPICILLIN TRIHYDRATE | EQ 100MG BASE/ML | FOR SUSPENSION;ORAL | Discontinued | None | No | No |
PRINCIPEN | AMPICILLIN/AMPICILLIN TRIHYDRATE | EQ 125MG BASE/5ML | FOR SUSPENSION;ORAL | Discontinued | None | No | No |
PRINCIPEN | AMPICILLIN/AMPICILLIN TRIHYDRATE | EQ 250MG BASE/5ML | FOR SUSPENSION;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 |
---|---|---|---|---|---|---|---|
03/03/1971 | 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 |
---|---|---|---|---|---|
06/30/1998 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
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07/11/1997 | SUPPL-27 | Labeling |
Label is not available on this site. |
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02/29/1996 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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02/03/1992 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |