Details for New Drug Application (NDA): 218933
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NDA 218933 describes AVERI, which is a drug marketed by Avion Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the AVERI profile page.
The generic ingredient in AVERI is desogestrel; ethinyl estradiol. There are eight drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the desogestrel; ethinyl estradiol profile page.
The generic ingredient in AVERI is desogestrel; ethinyl estradiol. There are eight drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the desogestrel; ethinyl estradiol profile page.
Summary for 218933
| Tradename: | AVERI |
| Applicant: | Avion Pharms |
| Ingredient: | desogestrel; ethinyl estradiol |
| Patents: | 0 |
Suppliers and Packaging for NDA: 218933
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AVERI | desogestrel; ethinyl estradiol | TABLET;ORAL-21 | 218933 | ANDA | Avion Pharmaceuticals, LLC | 75854-604 | 75854-604-01 | 1 BLISTER PACK in 1 CARTON (75854-604-01) / 1 KIT in 1 BLISTER PACK |
| AVERI | desogestrel; ethinyl estradiol | TABLET;ORAL-21 | 218933 | ANDA | Avion Pharmaceuticals, LLC | 75854-604 | 75854-604-03 | 3 BLISTER PACK in 1 CARTON (75854-604-03) / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-21 | Strength | 0.15MG;0.03MG | ||||
| Approval Date: | May 2, 2025 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.15MG;0.03MG | ||||
| Approval Date: | May 2, 2025 | TE: | AB | RLD: | No | ||||
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