Details for New Drug Application (NDA): 217000
NDA 217000 describes DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE, which is a drug marketed by Actavis Labs Fl Inc, Bionpharma, Ph Health, and Pharmobedient, and is included in five NDAs. It is available from four suppliers. Additional details are available on the DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE profile page.
The generic ingredient in DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE is doxylamine succinate; pyridoxine hydrochloride. There is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the doxylamine succinate; pyridoxine hydrochloride profile page.
The generic ingredient in DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE is doxylamine succinate; pyridoxine hydrochloride. There is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the doxylamine succinate; pyridoxine hydrochloride profile page.
Summary for 217000
| Tradename: | DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE |
| Applicant: | Bionpharma |
| Ingredient: | doxylamine succinate; pyridoxine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 217000
| Ingredient-type | Analogs/Derivatives Vitamin B 6 |
| Mechanism of Action | Histamine Receptor Antagonists |
Suppliers and Packaging for NDA: 217000
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE | doxylamine succinate; pyridoxine hydrochloride | TABLET, DELAYED RELEASE;ORAL | 217000 | ANDA | Bionpharma Inc., | 69452-206 | 69452-206-20 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (69452-206-20) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 10MG;10MG | ||||
| Approval Date: | Aug 4, 2023 | TE: | AB | RLD: | No | ||||
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