Details for New Drug Application (NDA): 204057
✉ Email this page to a colleague
NDA 204057 describes NORGESTIMATE AND ETHINYL ESTRADIOL, which is a drug marketed by Amneal Pharms, Glenmark Pharms Ltd, Glenmark Speclt, Lupin Ltd, Lupin Pharms, Mylan, Naari Pte Ltd, Watson Labs, and Xiromed, and is included in seventeen NDAs. It is available from nine suppliers. Additional details are available on the NORGESTIMATE AND ETHINYL ESTRADIOL profile page.
The generic ingredient in NORGESTIMATE AND ETHINYL ESTRADIOL is ethinyl estradiol; norgestimate. There are twenty-six drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestimate profile page.
The generic ingredient in NORGESTIMATE AND ETHINYL ESTRADIOL is ethinyl estradiol; norgestimate. There are twenty-six drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestimate profile page.
Summary for 204057
| Tradename: | NORGESTIMATE AND ETHINYL ESTRADIOL |
| Applicant: | Glenmark Speclt |
| Ingredient: | ethinyl estradiol; norgestimate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG | ||||
| Approval Date: | Feb 23, 2016 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
