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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074315
Company: SANDOZ

Products on ANDA 074315

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TERAZOSIN HYDROCHLORIDE	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	TABLET;ORAL	Discontinued	None	No	No
TERAZOSIN HYDROCHLORIDE	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	TABLET;ORAL	Discontinued	None	No	No
TERAZOSIN HYDROCHLORIDE	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Discontinued	None	No	No
TERAZOSIN HYDROCHLORIDE	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074315

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/31/1998	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74-315_Terazosin%20Hydrochloride_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74-315_Terazosin%20Hydrochloride_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74-315_Terazosin.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/13/2003	SUPPL-11	Labeling		Label is not available on this site.
03/05/2002	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
04/19/2002	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
09/04/2001	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
04/25/2001	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
02/22/2000	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
07/07/1999	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
04/06/2000	SUPPL-3	Labeling		Label is not available on this site.
04/06/2000	SUPPL-2	Manufacturing (CMC)-Packaging		Label is not available on this site.
07/07/1999	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for ANDA 074315

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/31/1998	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74-315_Terazosin%20Hydrochloride_prntlbl.pdf

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