Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 077182
Company: DR REDDYS LABS SA

Products on ANDA 077182

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DESOGESTREL AND ETHINYL ESTRADIOL	DESOGESTREL; ETHINYL ESTRADIOL	0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG	TABLET;ORAL-28	Discontinued	None	No	No
DESOGESTREL; ETHINYL ESTRADIOL	DESOGESTREL; ETHINYL ESTRADIOL	0.125MG/0.025MG	TABLET; ORAL-28	Prescription	None	No	No
DESOGESTREL; ETHINYL ESTRADIOL	DESOGESTREL; ETHINYL ESTRADIOL	0.15MG/0.025MG	TABLET; ORAL-28	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077182

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/24/2006	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
10/25/2019	SUPPL-14	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
08/02/2010	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
03/19/2009	SUPPL-4	Labeling		Label is not available on this site.