Details for New Drug Application (NDA): 200383
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NDA 200383 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 200383
| Tradename: | NORGESTIMATE AND ETHINYL ESTRADIOL |
| Applicant: | Naari Pte Ltd |
| Ingredient: | ethinyl estradiol; norgestimate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 200383
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NORGESTIMATE AND ETHINYL ESTRADIOL | ethinyl estradiol; norgestimate | TABLET;ORAL-28 | 200383 | ANDA | Proficient Rx LP | 71205-170 | 71205-170-28 | 1 BLISTER PACK in 1 CARTON (71205-170-28) / 1 KIT in 1 BLISTER PACK * 7 TABLET in 1 BLISTER PACK * 7 TABLET in 1 BLISTER PACK * 7 TABLET in 1 BLISTER PACK * 7 TABLET in 1 BLISTER PACK |
| NORGESTIMATE AND ETHINYL ESTRADIOL | ethinyl estradiol; norgestimate | TABLET;ORAL-28 | 200383 | ANDA | Naari Pte Limited | 79929-009 | 79929-009-07 | 3 CARTON in 1 CARTON (79929-009-07) / 1 KIT in 1 CARTON |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG | ||||
| Approval Date: | Apr 7, 2015 | TE: | AB | RLD: | No | ||||
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