Details for New Drug Application (NDA): 200490
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The generic ingredient in LEVONORGESTREL AND ETHINYL ESTRADIOL is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
Summary for 200490
Tradename: | LEVONORGESTREL AND ETHINYL ESTRADIOL |
Applicant: | Xiromed |
Ingredient: | ethinyl estradiol; levonorgestrel |
Patents: | 0 |
Suppliers and Packaging for NDA: 200490
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEVONORGESTREL AND ETHINYL ESTRADIOL | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 200490 | ANDA | Mylan Pharmaceuticals Inc. | 0378-7281 | 0378-7281-53 | 3 POUCH in 1 CARTON (0378-7281-53) / 1 BLISTER PACK in 1 POUCH (0378-7281-85) / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.03MG;0.15MG | ||||
Approval Date: | Apr 21, 2015 | TE: | AB | RLD: | No |
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