Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075672
Company: ACTAVIS ELIZABETH

Products on ANDA 075672

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET;ORAL	Discontinued	None	No	No
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET;ORAL	Discontinued	None	No	No
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075672

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/25/2000	ORIG-1	Approval			Letter (PDF) Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75672ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75672ta.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/26/2002	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
03/06/2002	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
11/02/2001	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.