Details for New Drug Application (NDA): 206866
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The generic ingredient in AYUNA 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 206866
Tradename: | AYUNA |
Applicant: | Aurobindo Pharma |
Ingredient: | ethinyl estradiol; levonorgestrel |
Patents: | 0 |
Suppliers and Packaging for NDA: 206866
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AYUNA | ethinyl estradiol; levonorgestrel | TABLET;ORAL-28 | 206866 | ANDA | Afaxys Pharma, LLC | 50102-230 | 50102-230-23 | 3 POUCH in 1 CARTON (50102-230-23) / 1 BLISTER PACK in 1 POUCH (50102-230-21) / 1 KIT in 1 BLISTER PACK |
AYUNA | ethinyl estradiol; levonorgestrel | TABLET;ORAL-28 | 206866 | ANDA | RPK Pharmaceuticals, Inc. | 53002-2683 | 53002-2683-1 | 1 KIT in 1 BLISTER PACK (53002-2683-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.03MG;0.15MG | ||||
Approval Date: | Sep 23, 2016 | TE: | AB | RLD: | No |
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