Details for New Drug Application (NDA): 091623
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NDA 091623 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 091623
| Tradename: | THIAMINE HYDROCHLORIDE |
| Applicant: | Mylan Institutional |
| Ingredient: | thiamine hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 091623
Suppliers and Packaging for NDA: 091623
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| THIAMINE HYDROCHLORIDE | thiamine hydrochloride | INJECTABLE;INJECTION | 091623 | ANDA | Henry Schein, Inc. | 0404-9963 | 0404-9963-02 | 1 VIAL, MULTI-DOSE in 1 BAG (0404-9963-02) / 2 mL in 1 VIAL, MULTI-DOSE |
| THIAMINE HYDROCHLORIDE | thiamine hydrochloride | INJECTABLE;INJECTION | 091623 | ANDA | Mylan Institutional LLC | 67457-196 | 67457-196-02 | 25 VIAL, MULTI-DOSE in 1 CARTON (67457-196-02) / 2 mL in 1 VIAL, MULTI-DOSE (67457-196-00) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 100MG/ML | ||||
| Approval Date: | Jun 25, 2012 | TE: | AP | RLD: | No | ||||
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