Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020286
Company: BRISTOL MYERS SQUIBB

Products on NDA 020286

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MONOPRIL-HCT	FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE	20MG;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
MONOPRIL-HCT	FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE	10MG;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020286

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/30/1994	ORIG-1	Approval	Type 4 - New Combination	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
02/09/2009	SUPPL-8	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019915s042,020286s008ltr.pdf
10/29/2003	SUPPL-6	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19915slr038,20286slr006ltr.pdf
03/24/2000	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
02/16/2001	SUPPL-4	Labeling		Label is not available on this site.
05/20/1997	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
07/24/1996	SUPPL-2	Labeling		Label is not available on this site.
03/03/1995	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.