Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050520
Company: PFIZER
Company: PFIZER
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SPECTROBID | BACAMPICILLIN HYDROCHLORIDE | 400MG | TABLET;ORAL | Discontinued | None | No | No |
SPECTROBID | BACAMPICILLIN HYDROCHLORIDE | 800MG | TABLET;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 |
---|---|---|---|---|---|---|---|
12/22/1980 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/29/1992 | SUPPL-10 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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07/27/1982 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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11/23/1981 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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10/07/1981 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/14/1981 | SUPPL-6 | Labeling |
Label is not available on this site. |
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09/12/1983 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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09/12/1983 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/02/1983 | SUPPL-3 | Labeling |
Label is not available on this site. |
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12/29/1982 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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11/23/1982 | SUPPL-1 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |