Details for New Drug Application (NDA): 218471
✉ Email this page to a colleague
NDA 218471 describes THIAMINE HYDROCHLORIDE, which is a drug marketed by Abraxis Pharm, Aspiro, Bel Mar, Caplin, Dell Labs, Dr Reddys, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Hospira, Luitpold, Mylan Institutional, Parke Davis, Sagent Pharms Inc, Steriscience Speclts, Watson Labs, West-ward Pharms Int, and Wyeth Ayerst, and is included in nineteen NDAs. It is available from fourteen suppliers. Additional details are available on the THIAMINE HYDROCHLORIDE profile page.
The generic ingredient in THIAMINE HYDROCHLORIDE is thiamine hydrochloride. There are seven drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the thiamine hydrochloride profile page.
The generic ingredient in THIAMINE HYDROCHLORIDE is thiamine hydrochloride. There are seven drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the thiamine hydrochloride profile page.
Summary for 218471
| Tradename: | THIAMINE HYDROCHLORIDE |
| Applicant: | Aspiro |
| Ingredient: | thiamine hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 218471
Suppliers and Packaging for NDA: 218471
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| THIAMINE HYDROCHLORIDE | thiamine hydrochloride | INJECTABLE;INJECTION | 218471 | ANDA | Camber Pharmaceuticals, Inc. | 31722-363 | 31722-363-32 | 25 VIAL, MULTI-DOSE in 1 TRAY (31722-363-32) / 2 mL in 1 VIAL, MULTI-DOSE (31722-363-31) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 100MG/ML | ||||
| Approval Date: | Nov 6, 2024 | TE: | AP | RLD: | No | ||||
Complete Access Available with Subscription
