Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075055
Company: IVAX SUB TEVA PHARMS

Products on ANDA 075055

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CAPTOPRIL AND HYDROCHLOROTHIAZIDE	CAPTOPRIL; HYDROCHLOROTHIAZIDE	25MG;15MG	TABLET;ORAL	Discontinued	None	No	No
CAPTOPRIL AND HYDROCHLOROTHIAZIDE	CAPTOPRIL; HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET;ORAL	Discontinued	None	No	No
CAPTOPRIL AND HYDROCHLOROTHIAZIDE	CAPTOPRIL; HYDROCHLOROTHIAZIDE	50MG;25MG	TABLET;ORAL	Discontinued	None	No	No
CAPTOPRIL AND HYDROCHLOROTHIAZIDE	CAPTOPRIL; HYDROCHLOROTHIAZIDE	50MG;15MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075055

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/18/1998	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75055ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/29/2002	SUPPL-10	Manufacturing (CMC)-Facility		Label is not available on this site.
03/12/2002	SUPPL-9	Manufacturing (CMC)-Facility		Label is not available on this site.
11/07/2001	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
04/13/2001	SUPPL-6	Manufacturing (CMC)-Facility		Label is not available on this site.
04/13/2001	SUPPL-5	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
04/13/2001	SUPPL-4	Manufacturing (CMC)-Facility		Label is not available on this site.
03/28/2000	SUPPL-3	Manufacturing (CMC)-Facility		Label is not available on this site.
01/28/2000	SUPPL-2	Manufacturing (CMC)-Facility		Label is not available on this site.
07/23/1999	SUPPL-1	Manufacturing (CMC)-Facility		Label is not available on this site.