Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075478
Company: BARR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NORTREL 7/7/7 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG TABLET;ORAL-21 Prescription None No No
NORTREL 7/7/7 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG TABLET;ORAL-28 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
08/30/2002 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75478TA.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/26/2016 SUPPL-17 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

01/20/2015 SUPPL-15 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

12/31/2014 SUPPL-13 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

04/20/2004 SUPPL-3 Labeling

Label is not available on this site.

NORTREL 7/7/7

TABLET;ORAL-28; 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALYACEN 7/7/7 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG TABLET;ORAL-28 Prescription No AB 091636 GLENMARK GENERICS
CYCLAFEM 7/7/7 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG TABLET;ORAL-28 Prescription No AB 076338 VINTAGE PHARMS LLC
DASETTA 7/7/7 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG TABLET;ORAL-28 Prescription No AB 090946 NOVAST LABS LTD
NORTREL 7/7/7 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG TABLET;ORAL-28 Prescription No AB 075478 BARR
NYLIA 7/7/7 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG TABLET;ORAL-28 Prescription No AB 207054 AUROBINDO PHARMA LTD
ORTHO-NOVUM 7/7/7-28 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG TABLET;ORAL-28 Prescription Yes AB 018985 JANSSEN PHARMS
PIRMELLA 7/7/7 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG TABLET;ORAL-28 Prescription No AB 201510 LUPIN LTD

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