Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076785
Company: BARR

Products on ANDA 076785

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KELNOR	ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE	0.035MG;1MG	TABLET;ORAL-28	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076785

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/23/2005	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-20	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
08/09/2017	SUPPL-15	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 076785

KELNOR

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
ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE	0.035MG;1MG	TABLET;ORAL-28	Prescription	No	AB	204703	MYLAN LABS LTD
KELNOR	ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE	0.035MG;1MG	TABLET;ORAL-28	Prescription	No	AB	076785	BARR
LO-MALMOREDE	ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE	0.035MG;1MG	TABLET;ORAL-28	Prescription	No	AB	209548	NOVAST LABS