Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201584
Company: LUPIN LTD
Company: LUPIN LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BLISOVI FE 1/20 | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.02MG;1MG | 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 |
---|---|---|---|---|---|---|---|
11/18/2015 | 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 |
---|---|---|---|---|---|
08/31/2020 | SUPPL-16 | Labeling-Container/Carton Labels |
Label is not available on this site. |
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09/26/2018 | SUPPL-6 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
09/26/2018 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
BLISOVI FE 1/20
TABLET;ORAL-28; 0.02MG;1MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AUROVELA FE 1/20 | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.02MG;1MG | TABLET;ORAL-28 | Prescription | No | AB | 207505 | AUROBINDO PHARMA |
BLISOVI FE 1/20 | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.02MG;1MG | TABLET;ORAL-28 | Prescription | No | AB | 201584 | LUPIN LTD |
HAILEY FE 1/20 | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.02MG;1MG | TABLET;ORAL-28 | Prescription | No | AB | 206597 | GLENMARK PHARMS LTD |
JUNEL FE 1/20 | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.02MG;1MG | TABLET;ORAL-28 | Prescription | No | AB | 076081 | BARR |
LARIN FE 1/20 | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.02MG;1MG | TABLET;ORAL-28 | Prescription | No | AB | 091454 | NOVAST LABS |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.02MG;1MG | TABLET;ORAL-28 | Prescription | No | AB | 202772 | XIROMED |