Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070686
Company: DR REDDYS LABS SA

Products on ANDA 070686

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NORETHINDRONE AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; NORETHINDRONE	0.035MG;0.5MG	TABLET;ORAL-28	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 070686

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-38	Labeling-Package Insert		Label is not available on this site.
04/22/2022	SUPPL-37	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
06/26/2002	SUPPL-16	Manufacturing (CMC)-Control		Label is not available on this site.
05/21/2002	SUPPL-14	Manufacturing (CMC)-Facility		Label is not available on this site.
10/31/2001	SUPPL-13	Manufacturing (CMC)-Facility		Label is not available on this site.
08/27/2001	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
05/08/2002	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.