Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201661
Company: LUPIN LTD
Company: LUPIN LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NIKKI | DROSPIRENONE; ETHINYL ESTRADIOL | 3MG;0.02MG | TABLET;ORAL | 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 |
---|---|---|---|---|---|---|---|
05/27/2014 | 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 |
---|---|---|---|---|---|
10/24/2023 | SUPPL-18 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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10/24/2023 | SUPPL-17 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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04/03/2020 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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10/24/2023 | SUPPL-8 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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03/11/2019 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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03/11/2019 | SUPPL-4 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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03/11/2019 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
NIKKI
TABLET;ORAL; 3MG;0.02MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DROSPIRENONE AND ETHINYL ESTRADIOL | DROSPIRENONE; ETHINYL ESTRADIOL | 3MG;0.02MG | TABLET;ORAL | Prescription | No | AB | 204296 | GLENMARK PHARMS LTD |
DROSPIRENONE AND ETHINYL ESTRADIOL | DROSPIRENONE; ETHINYL ESTRADIOL | 3MG;0.02MG | TABLET;ORAL | Prescription | No | AB | 211944 | HETERO LABS |
DROSPIRENONE AND ETHINYL ESTRADIOL | DROSPIRENONE; ETHINYL ESTRADIOL | 3MG;0.02MG | TABLET;ORAL | Prescription | No | AB | 203291 | HLTHCARE |
DROSPIRENONE AND ETHINYL ESTRADIOL | DROSPIRENONE; ETHINYL ESTRADIOL | 3MG;0.02MG | TABLET;ORAL | Prescription | No | AB | 078833 | WATSON LABS |
DROSPIRENONE AND ETHINYL ESTRADIOL | DROSPIRENONE; ETHINYL ESTRADIOL | 3MG;0.02MG | TABLET;ORAL | Prescription | No | AB | 202594 | XIROMED |
LO-ZUMANDIMINE | DROSPIRENONE; ETHINYL ESTRADIOL | 3MG;0.02MG | TABLET;ORAL | Prescription | No | AB | 209632 | AUROBINDO PHARMA LTD |
LORYNA | DROSPIRENONE; ETHINYL ESTRADIOL | 3MG;0.02MG | TABLET;ORAL | Prescription | No | AB | 079221 | XIROMED |
MELAMISA | DROSPIRENONE; ETHINYL ESTRADIOL | 3MG;0.02MG | TABLET;ORAL | Prescription | No | AB | 202016 | NOVAST LABS |
NIKKI | DROSPIRENONE; ETHINYL ESTRADIOL | 3MG;0.02MG | TABLET;ORAL | Prescription | No | AB | 201661 | LUPIN LTD |
YAZ | DROSPIRENONE; ETHINYL ESTRADIOL | 3MG;0.02MG | TABLET;ORAL | Prescription | Yes | AB | 021676 | BAYER HLTHCARE |