Details for New Drug Application (NDA): 091623
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The generic ingredient in THIAMINE HYDROCHLORIDE is thiamine hydrochloride. There are seven drug master file entries for this compound. Twelve 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 |
Formulation / Manufacturing: | see details |
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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