Details for New Drug Application (NDA): 206851
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The generic ingredient in SIMPESSE is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
Summary for 206851
Tradename: | SIMPESSE |
Applicant: | Aurobindo Pharma |
Ingredient: | ethinyl estradiol; levonorgestrel |
Patents: | 0 |
Suppliers and Packaging for NDA: 206851
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SIMPESSE | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 206851 | ANDA | Aurobindo Pharma Limited | 65862-864 | 65862-864-95 | 2 POUCH in 1 CARTON (65862-864-95) / 1 BLISTER PACK in 1 POUCH (65862-864-94) / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.03MG,0.01MG;0.15MG,N/A | ||||
Approval Date: | Apr 7, 2017 | TE: | AB | RLD: | No |
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