Details for New Drug Application (NDA): 206853
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The generic ingredient in SIMLIYA is desogestrel; ethinyl estradiol. There are eight drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the desogestrel; ethinyl estradiol profile page.
Summary for 206853
Tradename: | SIMLIYA |
Applicant: | Aurobindo Pharma |
Ingredient: | desogestrel; ethinyl estradiol |
Patents: | 0 |
Suppliers and Packaging for NDA: 206853
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SIMLIYA | desogestrel; ethinyl estradiol | TABLET;ORAL-28 | 206853 | ANDA | Aurobindo Pharma Limited | 65862-886 | 65862-886-88 | 3 POUCH in 1 CARTON (65862-886-88) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK |
SIMLIYA | desogestrel; ethinyl estradiol | TABLET;ORAL-28 | 206853 | ANDA | Aurobindo Pharma Limited | 65862-886 | 65862-886-92 | 6 POUCH in 1 CARTON (65862-886-92) / 1 BLISTER PACK in 1 POUCH (65862-886-28) / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.15MG,N/A;0.02MG,0.01MG | ||||
Approval Date: | Mar 22, 2017 | TE: | AB | RLD: | No |
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