Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050520
Company: PFIZER

Products on NDA 050520

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050520

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.