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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075863
Company: BARR

Products on ANDA 075863

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KARIVA	DESOGESTREL; ETHINYL ESTRADIOL	0.15MG,N/A;0.02MG,0.01MG	TABLET;ORAL-28	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075863

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/05/2002	ORIG-1	Approval			Letter (PDF) Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75863.ta.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75863.ap.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/10/2024	SUPPL-37	Labeling-Package Insert, Labeling-Patient Package Insert, Labeling		Label is not available on this site.
06/10/2024	SUPPL-35	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
04/29/2022	SUPPL-34	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
08/09/2017	SUPPL-26	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/28/2013	SUPPL-21	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
02/28/2013	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
09/24/2009	SUPPL-15	Labeling		Label is not available on this site.
10/04/2002	SUPPL-2	Manufacturing (CMC)-Facility		Label is not available on this site.
10/04/2002	SUPPL-1	Manufacturing (CMC)-Facility		Label is not available on this site.

Therapeutic Equivalents for ANDA 075863

KARIVA

TABLET;ORAL-28; 0.15MG,N/A;0.02MG,0.01MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BEKYREE	DESOGESTREL; ETHINYL ESTRADIOL	0.15MG,N/A;0.02MG,0.01MG	TABLET;ORAL-28	Prescription	No	AB	202226	LUPIN
DESOGESTREL AND ETHINYL ESTRADIOL	DESOGESTREL; ETHINYL ESTRADIOL	0.15MG,N/A;0.02MG,0.01MG	TABLET;ORAL-28	Prescription	No	AB	209170	NAARI PTE
DESOGESTREL AND ETHINYL ESTRADIOL	DESOGESTREL; ETHINYL ESTRADIOL	0.15MG,N/A;0.02MG,0.01MG	TABLET;ORAL-28	Prescription	No	AB	202296	XIROMED
KARIVA	DESOGESTREL; ETHINYL ESTRADIOL	0.15MG,N/A;0.02MG,0.01MG	TABLET;ORAL-28	Prescription	No	AB	075863	BARR
PIMTREA	DESOGESTREL; ETHINYL ESTRADIOL	0.15MG,N/A;0.02MG,0.01MG	TABLET;ORAL-28	Prescription	No	AB	091247	NOVAST LABS
SIMLIYA	DESOGESTREL; ETHINYL ESTRADIOL	0.15MG,N/A;0.02MG,0.01MG	TABLET;ORAL-28	Prescription	No	AB	206853	AUROBINDO PHARMA
VIORELE	DESOGESTREL; ETHINYL ESTRADIOL	0.15MG,N/A;0.02MG,0.01MG	TABLET;ORAL-28	Prescription	No	AB	091346	GLENMARK PHARMS LTD
VOLNEA	DESOGESTREL; ETHINYL ESTRADIOL	0.15MG,N/A;0.02MG,0.01MG	TABLET;ORAL-28	Prescription	No	AB	202689	XIROMED

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