Details for New Drug Application (NDA): 203865
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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-one 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: | Amneal Pharms |
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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