Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202296
Company: XIROMED
Company: XIROMED
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DESOGESTREL AND ETHINYL ESTRADIOL | DESOGESTREL; ETHINYL ESTRADIOL | 0.15MG,N/A;0.02MG,0.01MG | TABLET;ORAL-28 | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
08/30/2013 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/18/2024 | SUPPL-10 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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06/18/2024 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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04/29/2022 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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08/09/2017 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
DESOGESTREL AND ETHINYL ESTRADIOL
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 | NAARI PTE LTD |
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 |