Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091408
Company: LUPIN LTD
Company: LUPIN LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
KURVELO | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG;0.15MG | 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 |
---|---|---|---|---|---|---|---|
10/17/2012 | 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 |
---|---|---|---|---|---|
02/03/2023 | SUPPL-15 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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04/29/2022 | SUPPL-14 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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03/01/2022 | SUPPL-13 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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03/02/2020 | SUPPL-10 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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03/02/2020 | SUPPL-9 | Labeling-Container/Carton Labels, Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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03/02/2020 | SUPPL-7 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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08/09/2017 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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01/28/2014 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
KURVELO
TABLET;ORAL-28; 0.03MG;0.15MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ALTAVERA | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG;0.15MG | TABLET;ORAL-28 | Prescription | No | AB | 079102 | XIROMED |
AYUNA | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG;0.15MG | TABLET;ORAL-28 | Prescription | No | AB | 206866 | AUROBINDO PHARMA |
KURVELO | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG;0.15MG | TABLET;ORAL-28 | Prescription | No | AB | 091408 | LUPIN LTD |
LEVONORGESTREL AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG;0.15MG | TABLET;ORAL-28 | Prescription | No | AB | 207033 | NAARI PTE LTD |
LEVONORGESTREL AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG;0.15MG | TABLET;ORAL-28 | Prescription | No | AB | 091663 | XIROMED |
LEVORA 0.15/30-28 | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG;0.15MG | TABLET;ORAL-28 | Prescription | No | AB | 073594 | DR REDDYS LABS SA |
MARLISSA | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG;0.15MG | TABLET;ORAL-28 | Prescription | No | AB | 091452 | GLENMARK PHARMS LTD |
PORTIA-28 | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG;0.15MG | TABLET;ORAL-28 | Prescription | No | AB | 075866 | BARR |