Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070687
Company: WATSON LABS TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NORETHINDRONE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;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
01/29/1987 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
12/13/2002 SUPPL-19 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

12/13/2002 SUPPL-18 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

06/26/2002 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

05/21/2002 SUPPL-15 Manufacturing (CMC)-Facility

Label is not available on this site.

10/31/2001 SUPPL-14 Manufacturing (CMC)-Facility

Label is not available on this site.

08/27/2001 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

05/08/2002 SUPPL-11 Labeling

Label is not available on this site.

11/17/1997 SUPPL-10 Labeling

Label is not available on this site.

05/01/1997 SUPPL-9 Labeling

Label is not available on this site.

11/04/1993 SUPPL-8 Labeling

Label is not available on this site.

08/10/1993 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

03/15/1990 SUPPL-6 Labeling

Label is not available on this site.

07/28/1989 SUPPL-5 Labeling

Label is not available on this site.

11/19/1987 SUPPL-4 Labeling

Label is not available on this site.

09/28/1987 SUPPL-3 Labeling

Label is not available on this site.

02/25/1987 SUPPL-1 Labeling

Label is not available on this site.

NORETHINDRONE AND ETHINYL ESTRADIOL

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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