Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075863
Company: BARR
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/2002/75863.ap.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75863.ta.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/29/2022 | SUPPL-34 | Labeling-Patient Package Insert, Labeling-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. |
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 | 202296 | MYLAN LABS LTD |
DESOGESTREL AND ETHINYL ESTRADIOL | DESOGESTREL; ETHINYL ESTRADIOL | 0.15MG,N/A;0.02MG,0.01MG | TABLET;ORAL-28 | Prescription | No | AB | 209170 | NAARI PTE 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 |
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 |