Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050520
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.

07/27/1982 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

11/23/1981 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/07/1981 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

04/14/1981 SUPPL-6 Labeling

Label is not available on this site.

09/12/1983 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

09/12/1983 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

02/02/1983 SUPPL-3 Labeling

Label is not available on this site.

12/29/1982 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

11/23/1982 SUPPL-1 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

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