Register entry
Avion Pharmaceuticals, LLC
- Registered sites
- 1
- Drug products
- 13
- Live patents
- 4
- Countries
- 1
- Base
- United States
Authorisation
Registered operations
What the FDA has registered these sites to do. This is the regulatory record, not a marketing claim.
Finished drug manufactureRelabelling
Sites
Facilities
1| Site | Location | Operations | FEI |
|---|---|---|---|
| Avion Pharmaceuticals, LLC | Alpharetta, GAUnited States | Finished drug manufacture, Relabelling | 3010577308 |
Exclusivity
Patents
4Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| BALCOLTRA | ETHINYL ESTRADIOL; LEVONORGESTREL | Jun 2027 |
| DHIVY | CARBIDOPA; LEVODOPA | Mar 2039 |
Catalogue
Marketed products
13Showing 13 of 13.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| Balcoltra | levonorgestrel and ethinyl estradiol | KIT | NDA |
| Chromagen | ferrous asparto glycinate, ferrous fumarate, ascorbic acid, folic acid, levomefolate glucosamine, cyanocobalamin, zinc, and intrinsic factor | CAPSULE | UNAPPROVED DRUG OTHER |
| Dhivy | Carbidopa Levodopa | TABLET | NDA |
| Nicomide | niacinamide, zinc glycinate, levomefolate calcium, cupric oxide, selenium and chromium | TABLET | UNAPPROVED DRUG OTHER |
| Niferex | ferrous asparto glycinate, iron, ascorbic acid, folic acid, cyanocobalamin, zinc, and succinic acid | TABLET | UNAPPROVED DRUG OTHER |
| PRENATE DHA | ascorbic acid, cholecalciferol, .alpha.-tocopherol, dl-, folic acid, levomefolate calcium, pyridoxine hydrochloride, cyanocobalamin, calcium formate, ferrous asparto glycinate, magnesium oxide and doconexent | CAPSULE, GELATIN COATED | UNAPPROVED DRUG OTHER |
| PRENATE Enhance | ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, folic acid, pyridoxine hydrochloride, cyanocobalamin, biotin, calcium carbonate, ferrous fumarate, magnesium oxide, lactic acid and doconexent | CAPSULE, GELATIN COATED | UNAPPROVED DRUG OTHER |
| PRENATE Restore | ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, folic acid, pyridoxine hydrochloride, cyanocobalamin, biotin, calcium carbonate, ferrous fumarate, magnesium oxide, lactic acid and doconexent | CAPSULE, GELATIN COATED | UNAPPROVED DRUG OTHER |
| Prenate Chewable | calcium carbonate, cholecalciferol, magnesium oxide, boron, folic acid, levomefolate glucosamine, pyridoxine hydrochloride, cyanocobalamin, biotin and blueberry | TABLET, CHEWABLE | UNAPPROVED DRUG OTHER |
| Prenate Elite | .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, levomefolate calcium, calcium formate, ferrous asparto glycinate, cyanocobalamin, biotin, potassium iodide, magnesium oxide, zinc oxide and cupric oxide | TABLET, COATED | UNAPPROVED DRUG OTHER |
| Prenate Essential | ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, levomefolate calcium, cyanocobalamin, biotin, calcium formate, ferrous asparto glycinate, potassium iodide, magnesium oxide, doconexent and icosapent | CAPSULE, GELATIN COATED | UNAPPROVED DRUG OTHER |
| Prenate Mini | ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, levomefolate calcium, cyanocobalamin, biotin, calcium carbonate, ferrous asparto glycinate, iron, potassium iodide, magnesium oxide, doconexent and lowbush blueberry | CAPSULE, GELATIN COATED | UNAPPROVED DRUG OTHER |
| Prenate Pixie | ascorbic acid, biotin, cholecalciferol, cyanocobalamin, levomefolate calcium, folic acid, ferrous asparto glycinate, potassium iodide, pyridoxine hydrochloride, .alpha.-tocopherol acetate, dl-, Docosahexaenoic acid, and blueberry | TABLET, FILM COATED | UNAPPROVED DRUG OTHER |
Provenance
Facility and operations data from the FDA Drug Establishments Current Registration Site. Product data from the openFDA National Drug Code Directory. Patent and exclusivity data from the FDA Orange Book. Shortage data from the FDA drug shortage database. Contact details the FDA publishes for registered establishments are deliberately not reproduced here. This entry is compiled from public records and has not been claimed by the company.