Details for New Drug Application (NDA): 203164
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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 203164
Tradename: | LEVONORGESTREL AND ETHINYL ESTRADIOL |
Applicant: | Glenmark Pharms Ltd |
Ingredient: | ethinyl estradiol; levonorgestrel |
Patents: | 0 |
Suppliers and Packaging for NDA: 203164
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEVONORGESTREL AND ETHINYL ESTRADIOL | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 203164 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-672 | 68462-672-95 | 3 POUCH in 1 CARTON (68462-672-95) / 1 BLISTER PACK in 1 POUCH (68462-672-91) / 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: | Jun 12, 2015 | TE: | AB | RLD: | No |
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