Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 061370
Company: TEVA
Company: TEVA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AMPICILLIN TRIHYDRATE | AMPICILLIN/AMPICILLIN TRIHYDRATE | EQ 125MG BASE/5ML | FOR SUSPENSION;ORAL | Discontinued | None | No | No |
AMPICILLIN TRIHYDRATE | 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 |
---|---|---|---|---|---|---|---|
08/03/1971 | 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 |
---|---|---|---|---|---|
12/22/1997 | SUPPL-91 | Manufacturing (CMC) |
Label is not available on this site. |
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08/28/1996 | SUPPL-90 | Manufacturing (CMC) |
Label is not available on this site. |
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12/22/1994 | SUPPL-89 | Manufacturing (CMC) |
Label is not available on this site. |
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11/25/1991 | SUPPL-88 | Labeling |
Label is not available on this site. |