Register entry
- Registered sites
- 1
- Active NDC listings
- 13
- Labeller names
- 2
- Live patents
- 4
- Countries
- 1
- Base
- United States
Authorisation
Registered operations
Finished drug manufacture1Relabelling1
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Avion Pharmaceuticals, LLC | 1880 McFarland Pkwy Ste 105, Alpharetta, Georgia (GA) 30005, United States (USA) | Finished drug manufacture, Relabelling | 3010577308040348516 |
Catalogue
Drug listings by form and route
1313 active NDC listings: 13 human prescription drug. By marketing category: UNAPPROVED DRUG OTHER 11, NDA 2.
| Dosage form | NDCs |
|---|---|
| capsule, gelatin coated | 5 |
| tablet | 3 |
| capsule | 1 |
| kit | 1 |
| tablet, chewable | 1 |
| tablet, coated | 1 |
| tablet, film coated | 1 |
| Route | NDCs |
|---|---|
| oral | 12 |
| Labeller name on the listing | NDCs |
|---|---|
| avion pharmaceuticals, llc | 12 |
| avion pharmaceuticals | 1 |
Exclusivity
Patents and exclusivities
4| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 7838042 | BALCOLTRAethinyl estradiol; levonorgestrel | substance | Jun 2027 |
| 11033521 | DHIVYcarbidopa; levodopa | product | Mar 2039 |
| 11439613 | DHIVYcarbidopa; levodopa | use | Mar 2039 |
| 11819485 | DHIVYcarbidopa; levodopa | use | Mar 2039 |
Catalogue
Marketed products
13| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| Balcoltra | levonorgestrel and ethinyl estradiol | kit | 75854-602NDA |
| Chromagen | ferrous asparto glycinate, ferrous fumarate, ascorbic acid, folic acid, levomefolate glucosamine, cyanocobalamin, zinc, and intrinsic factor | capsule, oral | 75854-320UNAPPROVED DRUG OTHER |
| Dhivy | Carbidopa Levodopa | tablet, oral | 75854-701NDA |
| Nicomide | niacinamide, zinc glycinate, levomefolate calcium, cupric oxide, selenium and chromium | tablet, oral | 75854-343UNAPPROVED DRUG OTHER |
| Niferex | ferrous asparto glycinate, iron, ascorbic acid, folic acid, cyanocobalamin, zinc, and succinic acid | tablet, oral | 75854-344UNAPPROVED 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, oral | 75854-312UNAPPROVED 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, oral | 75854-309UNAPPROVED 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, oral | 75854-308UNAPPROVED DRUG OTHER |
| Prenate Chewable | calcium carbonate, cholecalciferol, magnesium oxide, boron, folic acid, levomefolate glucosamine, pyridoxine hydrochloride, cyanocobalamin, biotin and blueberry | tablet, chewable, oral | 75854-306UNAPPROVED 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, oral | 75854-314UNAPPROVED 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, oral | 75854-313UNAPPROVED 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, oral | 75854-315UNAPPROVED 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, oral | 75854-316UNAPPROVED DRUG OTHER |
Neighbours
Registered in the same town
1- Acella Pharmaceuticals, LLCAlpharetta, GA
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Enquiry
Common questions
- Is Avion Pharmaceuticals, LLC FDA approved?
- Avion Pharmaceuticals, LLC holds 1 FDA-registered establishment in the United States. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
- Where are Avion Pharmaceuticals, LLC's drugs manufactured?
- The FDA register lists Alpharetta, GA. Registered operations: finished drug manufacture, relabelling.
- What drugs does Avion Pharmaceuticals, LLC make?
- 13 products are listed under Avion Pharmaceuticals, LLC in the openFDA NDC Directory, most often as capsule, gelatin coated; tablet; capsule. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.