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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075808
Company: BARR

Products on ANDA 075808

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRI-SPRINTEC	ETHINYL ESTRADIOL; NORGESTIMATE	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET;ORAL-28	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075808

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/29/2003	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/075808_ORIGINAL APPROVAL_PACKAGE.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/27/2023	SUPPL-45	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
11/27/2023	SUPPL-43	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
04/29/2022	SUPPL-40	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
01/27/2022	SUPPL-34	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
04/13/2016	SUPPL-31	Labeling-Package Insert		Label is not available on this site.
04/13/2016	SUPPL-30	Labeling-Package Insert		Label is not available on this site.
02/21/2013	SUPPL-29	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 075808

TRI-SPRINTEC

TABLET;ORAL-28; 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NORGESTIMATE AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; NORGESTIMATE	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET;ORAL-28	Prescription	No	AB	200494	GLENMARK PHARMS LTD
NORGESTIMATE AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; NORGESTIMATE	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET;ORAL-28	Prescription	No	AB	205588	LUPIN
NORGESTIMATE AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; NORGESTIMATE	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET;ORAL-28	Prescription	No	AB	200383	NAARI PTE
TRI-ESTARYLLA	ETHINYL ESTRADIOL; NORGESTIMATE	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET;ORAL-28	Prescription	No	AB	090793	XIROMED
TRI-LINYAH	ETHINYL ESTRADIOL; NORGESTIMATE	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET;ORAL-28	Prescription	No	AB	090524	NOVAST LABS LTD
TRI-MILI	ETHINYL ESTRADIOL; NORGESTIMATE	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET;ORAL-28	Prescription	No	AB	205441	AUROBINDO PHARMA LTD
TRI-SPRINTEC	ETHINYL ESTRADIOL; NORGESTIMATE	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET;ORAL-28	Prescription	No	AB	075808	BARR

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