Details for New Drug Application (NDA): 080618
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NDA 080618 describes PYRIDOXINE HYDROCHLORIDE, which is a drug marketed by Bel Mar, Dell Labs, Dr Reddys, Elkins Sinn, Epic Pharma Llc, Fresenius Kabi Usa, Luitpold, Mylan Institutional, and Watson Labs, and is included in ten NDAs. It is available from two suppliers. Additional details are available on the PYRIDOXINE HYDROCHLORIDE profile page.
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.
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 |
| Formulation / Manufacturing: | see details |
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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