Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016820
Company: PFIZER

Products on NDA 016820

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EMETE-CON	BENZQUINAMIDE HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 016820

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/12/1974	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
01/16/1990	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
04/19/1989	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
11/25/1986	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
06/23/1983	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
04/16/1981	SUPPL-10	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
10/02/1979	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
10/02/1979	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
10/02/1979	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
12/14/1977	SUPPL-6	Labeling		Label is not available on this site.
12/14/1977	SUPPL-5	Manufacturing (CMC)-Formulation		Label is not available on this site.
12/07/2007	SUPPL-4	Labeling		Label is not available on this site.
08/14/1974	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
05/21/1974	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
08/06/1974	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.