Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201887
Company: LUPIN LTD
Company: LUPIN LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ENSKYCE | DESOGESTREL; ETHINYL ESTRADIOL | 0.15MG;0.03MG | 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 |
---|---|---|---|---|---|---|---|
03/07/2013 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/29/2022 | SUPPL-19 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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11/15/2019 | SUPPL-15 | Labeling-Container/Carton Labels |
Label is not available on this site. |
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05/23/2019 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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05/23/2019 | SUPPL-10 | Labeling-Patient Package Insert, Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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05/23/2019 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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08/09/2017 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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06/02/2016 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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06/19/2015 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
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04/01/2015 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
ENSKYCE
TABLET;ORAL-28; 0.15MG;0.03MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DESOGESTREL AND ETHINYL ESTRADIOL | DESOGESTREL; ETHINYL ESTRADIOL | 0.15MG;0.03MG | TABLET;ORAL-28 | Prescription | No | AB | 075256 | DURAMED PHARMS BARR |
DESOGESTREL AND ETHINYL ESTRADIOL | DESOGESTREL; ETHINYL ESTRADIOL | 0.15MG;0.03MG | TABLET;ORAL-28 | Prescription | No | AB | 207067 | NAARI PTE LTD |
DESOGESTREL AND ETHINYL ESTRADIOL | DESOGESTREL; ETHINYL ESTRADIOL | 0.15MG;0.03MG | TABLET;ORAL-28 | Prescription | No | AB | 091234 | NOVAST LABS |
DESOGESTREL AND ETHINYL ESTRADIOL | DESOGESTREL; ETHINYL ESTRADIOL | 0.15MG;0.03MG | TABLET;ORAL-28 | Prescription | No | AB | 076915 | WATSON LABS |
ENSKYCE | DESOGESTREL; ETHINYL ESTRADIOL | 0.15MG;0.03MG | TABLET;ORAL-28 | Prescription | No | AB | 201887 | LUPIN LTD |
ISIBLOOM | DESOGESTREL; ETHINYL ESTRADIOL | 0.15MG;0.03MG | TABLET;ORAL-28 | Prescription | No | AB | 202789 | XIROMED |
KALLIGA | DESOGESTREL; ETHINYL ESTRADIOL | 0.15MG;0.03MG | TABLET;ORAL-28 | Prescription | No | AB | 207081 | AUROBINDO PHARMA |