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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070687
Company: WATSON LABS TEVA

Products on ANDA 070687

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 070687

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
04/29/2022	SUPPL-44	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
02/24/2022	SUPPL-43	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
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.

Therapeutic Equivalents for ANDA 070687

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 PHARMS LTD
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	NAARI PTE LTD
NORETHINDRONE AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; NORETHINDRONE	0.035MG;1MG	TABLET;ORAL-28	Prescription	No	AB	070687	WATSON LABS TEVA
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

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