Drugs@FDA: FDA Approved Drug Products

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

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 PHARMACIA AND UPJOHN

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 PHARMACIA AND UPJOHN

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 PHARMACIA AND UPJOHN

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