Details for New Drug Application (NDA): 203865
NDA 203865 describes NORGESTIMATE AND ETHINYL ESTRADIOL, which is a drug marketed by Annora Pharma, Glenmark Pharms Ltd, Glenmark Speclt, Lupin, Lupin Pharms, Mylan, Naari Pte, Watson Labs, and Xiromed, and is included in eighteen NDAs. It is available from seven 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 is one drug master file entry for this compound. Eighteen 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 is one drug master file entry for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestimate profile page.
Summary for 203865
| Tradename: | NORGESTIMATE AND ETHINYL ESTRADIOL |
| Applicant: | Naari Pte |
| Ingredient: | ethinyl estradiol; norgestimate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 203865
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NORGESTIMATE AND ETHINYL ESTRADIOL | ethinyl estradiol; norgestimate | TABLET;ORAL-28 | 203865 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1551 | 69238-1551-6 | 1 BLISTER PACK in 1 CARTON (69238-1551-6) / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL-28 | Strength | 0.035MG;0.25MG | ||||
| Approval Date: | Oct 27, 2015 | TE: | RLD: | No | |||||
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