Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062946
Company: TEVA
Company: TEVA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AMOXICILLIN | AMOXICILLIN | 125MG/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 |
---|---|---|---|---|---|---|---|
11/01/1988 | 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 |
---|---|---|---|---|---|
02/01/2000 | SUPPL-9 | Labeling |
Label is not available on this site. |
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07/07/1999 | SUPPL-7 | Labeling |
Label is not available on this site. |
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09/13/1996 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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02/23/1994 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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02/24/1995 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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05/27/1993 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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05/27/1993 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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03/24/1992 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |