Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075863
Company: BARR
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
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
08/09/2017 SUPPL-26 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

02/28/2013 SUPPL-21 Labeling-Package Insert, Labeling-Patient 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.

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 LTD
DESOGESTREL AND ETHINYL ESTRADIOL DESOGESTREL; ETHINYL ESTRADIOL 0.15MG,N/A;0.02MG,0.01MG TABLET;ORAL-28 Prescription No AB 209170 ACCORD HLTHCARE
DESOGESTREL AND ETHINYL ESTRADIOL DESOGESTREL; ETHINYL ESTRADIOL 0.15MG,N/A;0.02MG,0.01MG TABLET;ORAL-28 Prescription No AB 206853 AUROBINDO PHARMA LTD
DESOGESTREL AND ETHINYL ESTRADIOL DESOGESTREL; ETHINYL ESTRADIOL 0.15MG,N/A;0.02MG,0.01MG TABLET;ORAL-28 Prescription No AB 076916 MAYNE PHARMA
DESOGESTREL AND ETHINYL ESTRADIOL DESOGESTREL; ETHINYL ESTRADIOL 0.15MG,N/A;0.02MG,0.01MG TABLET;ORAL-28 Prescription No AB 202296 MYLAN LABS LTD
KARIVA DESOGESTREL; ETHINYL ESTRADIOL 0.15MG,N/A;0.02MG,0.01MG TABLET;ORAL-28 Prescription No AB 075863 BARR
KIMIDESS DESOGESTREL; ETHINYL ESTRADIOL 0.15MG,N/A;0.02MG,0.01MG TABLET;ORAL-28 Prescription No AB 076681 VINTAGE PHARMS
PIMTREA DESOGESTREL; ETHINYL ESTRADIOL 0.15MG,N/A;0.02MG,0.01MG TABLET;ORAL-28 Prescription No AB 091247 NOVAST LABS LTD
VIORELE DESOGESTREL; ETHINYL ESTRADIOL 0.15MG,N/A;0.02MG,0.01MG TABLET;ORAL-28 Prescription No AB 091346 GLENMARK GENERICS
VOLNEA DESOGESTREL; ETHINYL ESTRADIOL 0.15MG,N/A;0.02MG,0.01MG TABLET;ORAL-28 Prescription No AB 202689 SANDOZ INC

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