Details for New Drug Application (NDA): 206866
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NDA 206866 describes AYUNA, which is a drug marketed by Aurobindo Pharma and is included in one NDA. It is available from three suppliers. Additional details are available on the AYUNA profile page.
The generic ingredient in AYUNA is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
The generic ingredient in AYUNA is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-three 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 | Aurobindo Pharma Limited | 65862-848 | 65862-848-88 | 3 POUCH in 1 CARTON (65862-848-88) / 1 BLISTER PACK in 1 POUCH (65862-848-28) / 1 KIT in 1 BLISTER PACK |
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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