Details for New Drug Application (NDA): 200538
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The generic ingredient in NORGESTIMATE AND ETHINYL ESTRADIOL is ethinyl estradiol; norgestimate. There are twenty-six drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestimate profile page.
Summary for 200538
Tradename: | NORGESTIMATE AND ETHINYL ESTRADIOL |
Applicant: | Glenmark Pharms Ltd |
Ingredient: | ethinyl estradiol; norgestimate |
Patents: | 0 |
Suppliers and Packaging for NDA: 200538
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NORGESTIMATE AND ETHINYL ESTRADIOL | ethinyl estradiol; norgestimate | TABLET;ORAL-28 | 200538 | ANDA | A-S Medication Solutions | 50090-2259 | 50090-2259-0 | 1 KIT in 1 KIT (50090-2259-0) |
NORGESTIMATE AND ETHINYL ESTRADIOL | ethinyl estradiol; norgestimate | TABLET;ORAL-28 | 200538 | ANDA | RPK Pharmaceuticals, Inc. | 53002-1732 | 53002-1732-1 | 1 BLISTER PACK in 1 PACKAGE (53002-1732-1) / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.035MG;0.25MG | ||||
Approval Date: | Apr 5, 2012 | TE: | AB | RLD: | No |
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