Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072696
Company: BARR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NORTREL 1/35-28 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;1MG TABLET;ORAL-28 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
02/28/1992 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
02/27/2013 SUPPL-23 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

12/04/2001 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

12/04/2001 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

12/11/2002 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/2001 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

03/13/2001 SUPPL-7 Labeling

Label is not available on this site.

12/21/1999 SUPPL-6 Manufacturing (CMC)-Facility

Label is not available on this site.

03/07/2001 SUPPL-5 Labeling

Label is not available on this site.

03/07/2001 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/07/2001 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/07/2001 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/07/2001 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

NORTREL 1/35-28

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALYACEN 1/35 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;1MG TABLET;ORAL-28 Prescription No AB 091634 GLENMARK GENERICS
CYCLAFEM 1/35 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;1MG TABLET;ORAL-28 Prescription No AB 076337 VINTAGE PHARMS LLC
DASETTA 1/35 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;1MG TABLET;ORAL-28 Prescription No AB 090948 NOVAST LABS LTD
NORETHINDRONE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;1MG TABLET;ORAL-28 Prescription No AB 206864 ACCORD HLTHCARE
NORETHINDRONE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;1MG TABLET;ORAL-28 Prescription No AB 070687 WATSON LABS TEVA
NORINYL 1+35 28-DAY ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;1MG TABLET;ORAL-28 Prescription No AB 017565 ALLERGAN
NORTREL 1/35-28 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;1MG TABLET;ORAL-28 Prescription No AB 072696 BARR
NYLIA 1/35 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;1MG TABLET;ORAL-28 Prescription No AB 207056 AUROBINDO PHARMA LTD
PIRMELLA 1/35 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;1MG TABLET;ORAL-28 Prescription No AB 201512 LUPIN LTD

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