Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203038
Company: GLENMARK GENERICS
Company: GLENMARK GENERICS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.0025MG;0.5MG | TABLET;ORAL | Prescription | AB | No | No |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.005MG;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 |
---|---|---|---|---|---|---|---|
04/02/2015 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/16/2024 | SUPPL-8 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
01/26/2024 | SUPPL-6 | Labeling-Patient Package Insert |
Label is not available on this site. |
||
01/13/2021 | SUPPL-1 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
TABLET;ORAL; 0.0025MG;0.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FYAVOLV | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.0025MG;0.5MG | TABLET;ORAL | Prescription | No | AB | 204213 | LUPIN LTD |
LERIBANE | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.0025MG;0.5MG | TABLET;ORAL | Prescription | No | AB | 203435 | NOVAST LABS |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.0025MG;0.5MG | TABLET;ORAL | Prescription | No | AB | 203038 | GLENMARK GENERICS |
TABLET;ORAL; 0.005MG;1MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FYAVOLV | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.005MG;1MG | TABLET;ORAL | Prescription | No | AB | 204213 | LUPIN LTD |
LERIBANE | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.005MG;1MG | TABLET;ORAL | Prescription | No | AB | 203435 | NOVAST LABS |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.005MG;1MG | TABLET;ORAL | Prescription | No | AB | 076221 | BARR LABS INC |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.005MG;1MG | TABLET;ORAL | Prescription | No | AB | 203038 | GLENMARK GENERICS |