Details for New Drug Application (NDA): 080618
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The generic ingredient in PYRIDOXINE HYDROCHLORIDE is pyridoxine hydrochloride. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the pyridoxine hydrochloride profile page.
Summary for 080618
Tradename: | PYRIDOXINE HYDROCHLORIDE |
Applicant: | Fresenius Kabi Usa |
Ingredient: | pyridoxine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 080618
Ingredient-type | Analogs/Derivatives Vitamin B 6 |
Medical Subject Heading (MeSH) Categories for 080618
Suppliers and Packaging for NDA: 080618
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PYRIDOXINE HYDROCHLORIDE | pyridoxine hydrochloride | INJECTABLE;INJECTION | 080618 | ANDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1410 | 51662-1410-1 | 1 mL in 1 VIAL (51662-1410-1) |
PYRIDOXINE HYDROCHLORIDE | pyridoxine hydrochloride | INJECTABLE;INJECTION | 080618 | ANDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1410 | 51662-1410-3 | 25 POUCH in 1 CASE (51662-1410-3) / 1 VIAL in 1 POUCH (51662-1410-2) / 1 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 100MG/ML | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes |
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