Details for New Drug Application (NDA): 200494
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NDA 200494 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 200494
| Tradename: | NORGESTIMATE AND ETHINYL ESTRADIOL |
| Applicant: | Glenmark Pharms Ltd |
| Ingredient: | ethinyl estradiol; norgestimate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 200494
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NORGESTIMATE AND ETHINYL ESTRADIOL | ethinyl estradiol; norgestimate | TABLET;ORAL-28 | 200494 | ANDA | A-S Medication Solutions | 50090-2603 | 50090-2603-0 | 1 KIT in 1 KIT (50090-2603-0) |
| NORGESTIMATE AND ETHINYL ESTRADIOL | ethinyl estradiol; norgestimate | TABLET;ORAL-28 | 200494 | ANDA | RPK Pharmaceuticals, Inc. | 53002-1733 | 53002-1733-1 | 1 BLISTER PACK in 1 PACKAGE (53002-1733-1) / 1 KIT in 1 BLISTER PACK |
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: | Jun 17, 2011 | TE: | AB | RLD: | No | ||||
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