Details for New Drug Application (NDA): 216395
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NDA 216395 describes QUIOFIC, which is a drug marketed by Solubiomix and is included in one NDA. It is available from two suppliers. Additional details are available on the QUIOFIC profile page.
The generic ingredient in QUIOFIC is folic acid. There are ten drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the folic acid profile page.
The generic ingredient in QUIOFIC is folic acid. There are ten drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the folic acid profile page.
Summary for 216395
| Tradename: | QUIOFIC |
| Applicant: | Solubiomix |
| Ingredient: | folic acid |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 216395
Suppliers and Packaging for NDA: 216395
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| QUIOFIC | folic acid | SOLUTION;ORAL | 216395 | NDA | Solubiomix, LLC | 69499-501 | 69499-501-75 | 75 mL in 1 BOTTLE (69499-501-75) |
| QUIOFIC | folic acid | SOLUTION;ORAL | 216395 | NDA AUTHORIZED GENERIC | Ayurax, LLC | 73308-501 | 73308-501-75 | 75 mL in 1 BOTTLE (73308-501-75) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 0.2MG/ML | ||||
| Approval Date: | Jan 26, 2026 | TE: | RLD: | Yes | |||||
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