Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207581
Company: AUROBINDO PHARMA
Company: AUROBINDO PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AUROVELA 1.5/30 | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.03MG;1.5MG | TABLET;ORAL-21 | 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 |
---|---|---|---|---|---|---|---|
06/26/2017 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/01/2024 | SUPPL-9 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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02/01/2024 | SUPPL-7 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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02/01/2024 | SUPPL-1 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
AUROVELA 1.5/30
TABLET;ORAL-21; 0.03MG;1.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AUROVELA 1.5/30 | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.03MG;1.5MG | TABLET;ORAL-21 | Prescription | No | AB | 207581 | AUROBINDO PHARMA |
HAILEY 1.5/30 | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.03MG;1.5MG | TABLET;ORAL-21 | Prescription | No | AB | 209297 | GLENMARK PHARMS |
JUNEL 1.5/30 | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.03MG;1.5MG | TABLET;ORAL-21 | Prescription | No | AB | 076381 | BARR |
LARIN 1.5/30 | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.03MG;1.5MG | TABLET;ORAL-21 | Prescription | No | AB | 202996 | NOVAST LABS |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.03MG;1.5MG | TABLET;ORAL-21 | Prescription | No | AB | 202770 | MYLAN LABS LTD |