Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075951
Company: BARR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NORETHINDRONE ACETATE NORETHINDRONE ACETATE 5MG TABLET;ORAL Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/25/2001 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75951_Norethindrone Acetate_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75951ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/075951_norethindrone_acetate_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/31/2006 SUPPL-10 Labeling

Label is not available on this site.

04/12/2005 SUPPL-8 Labeling

Label is not available on this site.

10/14/2004 SUPPL-4 Labeling

Label is not available on this site.

11/26/2001 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/25/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75951_Norethindrone Acetate_Prntlbl.pdf

NORETHINDRONE ACETATE

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NORETHINDRONE ACETATE NORETHINDRONE ACETATE 5MG TABLET;ORAL Prescription No AB 200275 AMNEAL PHARMS
NORETHINDRONE ACETATE NORETHINDRONE ACETATE 5MG TABLET;ORAL Prescription No AB 204236 AUROBINDO PHARMA LTD
NORETHINDRONE ACETATE NORETHINDRONE ACETATE 5MG TABLET;ORAL Prescription No AB 075951 BARR
NORETHINDRONE ACETATE NORETHINDRONE ACETATE 5MG TABLET;ORAL Prescription No AB 091090 GLENMARK GENERICS
NORETHINDRONE ACETATE NORETHINDRONE ACETATE 5MG TABLET;ORAL Prescription No AB 205278 MYLAN LABS LTD
NORETHINDRONE ACETATE NORETHINDRONE ACETATE 5MG TABLET;ORAL Prescription No AB 206490 PACK PHARMS LLC

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