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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074732
Company: MYLAN

Products on ANDA 074732

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TAMOXIFEN CITRATE	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET;ORAL	Prescription	AB	No	No
TAMOXIFEN CITRATE	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074732

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/20/2003	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/74732ta3.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/25/2023	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
02/02/2007	SUPPL-6	Labeling		Label is not available on this site.
03/02/2006	SUPPL-4	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 074732

TAMOXIFEN CITRATE

TABLET;ORAL; EQ 20MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TAMOXIFEN CITRATE	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	070929	ACTAVIS LABS FL INC
TAMOXIFEN CITRATE	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	090878	APOTEX
TAMOXIFEN CITRATE	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	075797	DR REDDYS LABS SA
TAMOXIFEN CITRATE	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	213358	EUGIA PHARMA
TAMOXIFEN CITRATE	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	074732	MYLAN
TAMOXIFEN CITRATE	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	206694	ZYDUS PHARMS

TABLET;ORAL; EQ 10MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TAMOXIFEN CITRATE	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	070929	ACTAVIS LABS FL INC
TAMOXIFEN CITRATE	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	090878	APOTEX
TAMOXIFEN CITRATE	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	075797	DR REDDYS LABS SA
TAMOXIFEN CITRATE	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	213358	EUGIA PHARMA
TAMOXIFEN CITRATE	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	074732	MYLAN
TAMOXIFEN CITRATE	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	206694	ZYDUS PHARMS

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