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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075804
Company: BARR

Products on ANDA 075804

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SPRINTEC	ETHINYL ESTRADIOL; NORGESTIMATE	0.035MG;0.25MG	TABLET;ORAL-28	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075804

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/25/2002	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075804_ORIGINAL APPROVAL_PACKAGE.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2022	SUPPL-36	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
01/28/2022	SUPPL-30	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
04/13/2016	SUPPL-27	Labeling-Package Insert		Label is not available on this site.
04/13/2016	SUPPL-26	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
01/31/2013	SUPPL-25	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
08/31/2011	SUPPL-23	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 075804

SPRINTEC

TABLET;ORAL-28; 0.035MG;0.25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ESTARYLLA	ETHINYL ESTRADIOL; NORGESTIMATE	0.035MG;0.25MG	TABLET;ORAL-28	Prescription	No	AB	090794	XIROMED
MILI	ETHINYL ESTRADIOL; NORGESTIMATE	0.035MG;0.25MG	TABLET;ORAL-28	Prescription	No	AB	205449	AUROBINDO PHARMA LTD
MONO-LINYAH	ETHINYL ESTRADIOL; NORGESTIMATE	0.035MG;0.25MG	TABLET;ORAL-28	Prescription	No	AB	090523	NOVAST LABS LTD
NORGESTIMATE AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; NORGESTIMATE	0.035MG;0.25MG	TABLET;ORAL-28	Prescription	No	AB	200538	GLENMARK PHARMS LTD
NORGESTIMATE AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; NORGESTIMATE	0.035MG;0.25MG	TABLET;ORAL-28	Prescription	No	AB	205630	LUPIN LTD
NORGESTIMATE AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; NORGESTIMATE	0.035MG;0.25MG	TABLET;ORAL-28	Prescription	No	AB	200384	NAARI PTE LTD
PREVIFEM	ETHINYL ESTRADIOL; NORGESTIMATE	0.035MG;0.25MG	TABLET;ORAL-28	Prescription	No	AB	076334	VINTAGE PHARMS LLC
SPRINTEC	ETHINYL ESTRADIOL; NORGESTIMATE	0.035MG;0.25MG	TABLET;ORAL-28	Prescription	No	AB	075804	BARR

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