Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090293
Company: VINTAGE PHARMS
Company: VINTAGE PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GILDESS 24 FE | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.02MG;1MG | 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 |
---|---|---|---|---|---|---|---|
12/01/2014 | ORIG-1 | Approval |
Label is not available on this site. |
GILDESS 24 FE
TABLET;ORAL; 0.02MG;1MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AUROVELA 24 FE | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.02MG;1MG | TABLET;ORAL | Prescription | No | AB | 207504 | AUROBINDO PHARMA |
BLISOVI 24 FE | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.02MG;1MG | TABLET;ORAL | Prescription | No | AB | 091398 | LUPIN LTD |
FINZALA | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.02MG;1MG | TABLET;ORAL | Prescription | No | AB | 210087 | TEVA PHARMS USA INC |
GILDESS 24 FE | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.02MG;1MG | TABLET;ORAL | Prescription | No | AB | 090293 | VINTAGE PHARMS |
HAILEY 24 FE | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.02MG;1MG | TABLET;ORAL | Prescription | No | AB | 204847 | GLENMARK PHARMS LTD |
LARIN 24 FE | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.02MG;1MG | TABLET;ORAL | Prescription | No | AB | 202994 | NOVAST LABS |
MIBELAS 24 FE | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.02MG;1MG | TABLET;ORAL | Prescription | No | AB | 206287 | LUPIN |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.02MG;1MG | TABLET;ORAL | Prescription | No | AB | 090938 | BARR LABS INC |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.02MG;1MG | TABLET;ORAL | Prescription | No | AB | 210369 | GLENMARK PHARMS LTD |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.02MG;1MG | TABLET;ORAL | Prescription | No | AB | 209609 | XIROMED |
OSHIH | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.02MG;1MG | TABLET;ORAL | Prescription | No | AB | 216558 | AUROBINDO PHARMA |