Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040159
Company: BARR

Products on ANDA 040159

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MEDROXYPROGESTERONE ACETATE	MEDROXYPROGESTERONE ACETATE	2.5MG	TABLET;ORAL	Prescription	AB	No	No
MEDROXYPROGESTERONE ACETATE	MEDROXYPROGESTERONE ACETATE	5MG	TABLET;ORAL	Prescription	AB	No	No
MEDROXYPROGESTERONE ACETATE	MEDROXYPROGESTERONE ACETATE	10MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040159

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/09/1996	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/07/2021	SUPPL-29	Labeling-Patient Package Insert		Label is not available on this site.
12/26/2007	SUPPL-23	Labeling		Label is not available on this site.
04/10/2002	SUPPL-21	Manufacturing (CMC)-Control		Label is not available on this site.
10/26/2001	SUPPL-20	Labeling		Label is not available on this site.
12/14/2001	SUPPL-19	Manufacturing (CMC)-Control		Label is not available on this site.
05/16/2000	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
09/24/1999	SUPPL-17	Labeling		Label is not available on this site.
12/21/1999	SUPPL-16	Manufacturing (CMC)-Facility		Label is not available on this site.
01/24/2000	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
07/07/1999	SUPPL-14	Labeling		Label is not available on this site.
05/20/1999	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
03/26/1999	SUPPL-12	Labeling		Label is not available on this site.
03/26/1999	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
02/05/1999	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
12/01/1998	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
03/11/1999	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
09/25/1998	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
09/25/1998	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
12/27/1996	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 040159

MEDROXYPROGESTERONE ACETATE

TABLET;ORAL; 2.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MEDROXYPROGESTERONE ACETATE	MEDROXYPROGESTERONE ACETATE	2.5MG	TABLET;ORAL	Prescription	No	AB	040159	BARR
PROVERA	MEDROXYPROGESTERONE ACETATE	2.5MG	TABLET;ORAL	Prescription	Yes	AB	011839	PFIZER

TABLET;ORAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MEDROXYPROGESTERONE ACETATE	MEDROXYPROGESTERONE ACETATE	5MG	TABLET;ORAL	Prescription	No	AB	040159	BARR
PROVERA	MEDROXYPROGESTERONE ACETATE	5MG	TABLET;ORAL	Prescription	Yes	AB	011839	PFIZER

TABLET;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MEDROXYPROGESTERONE ACETATE	MEDROXYPROGESTERONE ACETATE	10MG	TABLET;ORAL	Prescription	No	AB	040159	BARR
PROVERA	MEDROXYPROGESTERONE ACETATE	10MG	TABLET;ORAL	Prescription	Yes	AB	011839	PFIZER