Details for New Drug Application (NDA): 215692
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NDA 215692 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, Gland, Hospira, Luitpold, Mylan Institutional, Onesource Specialty, Parke Davis, Sagent Pharms Inc, Watson Labs, West-ward Pharms Int, and Wyeth Ayerst, and is included in twenty NDAs. It is available from sixteen 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. Sixteen 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. Sixteen suppliers are listed for this compound. Additional details are available on the thiamine hydrochloride profile page.
Summary for 215692
| Tradename: | THIAMINE HYDROCHLORIDE |
| Applicant: | Caplin |
| Ingredient: | thiamine hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 215692
Suppliers and Packaging for NDA: 215692
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| THIAMINE HYDROCHLORIDE | thiamine hydrochloride | INJECTABLE;INJECTION | 215692 | ANDA | Caplin Steriles Limited | 65145-129 | 65145-129-25 | 25 VIAL, MULTI-DOSE in 1 CARTON (65145-129-25) / 2 mL in 1 VIAL, MULTI-DOSE (65145-129-01) |
| THIAMINE HYDROCHLORIDE | thiamine hydrochloride | INJECTABLE;INJECTION | 215692 | ANDA | Armas Pharmaceuticals Inc. | 72485-507 | 72485-507-25 | 25 VIAL, MULTI-DOSE in 1 CARTON (72485-507-25) / 2 mL in 1 VIAL, MULTI-DOSE (72485-507-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 100MG/ML | ||||
| Approval Date: | Mar 6, 2023 | TE: | AP | RLD: | No | ||||
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