Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213418
Company: GLENMARK PHARMS LTD
Company: GLENMARK PHARMS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.02MG;1MG | CAPSULE;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 |
---|---|---|---|---|---|---|---|
07/27/2022 | 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 |
---|---|---|---|---|---|
01/09/2024 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
CAPSULE;ORAL; 0.02MG;1MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
GEMMILY | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.02MG;1MG | CAPSULE;ORAL | Prescription | No | AB | 213317 | XIROMED |
MERZEE | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.02MG;1MG | CAPSULE;ORAL | Prescription | No | AB | 212706 | SLAYBACK PHARMA LLC |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.02MG;1MG | CAPSULE;ORAL | Prescription | No | AB | 213418 | GLENMARK PHARMS LTD |
TAYTULLA | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.02MG;1MG | CAPSULE;ORAL | Prescription | Yes | AB | 204426 | APIL |