Details for New Drug Application (NDA): 207825
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The generic ingredient in DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE is doxylamine succinate; pyridoxine hydrochloride. There are fourteen drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the doxylamine succinate; pyridoxine hydrochloride profile page.
Summary for 207825
Tradename: | DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE |
Applicant: | Mylan Pharms Inc |
Ingredient: | doxylamine succinate; pyridoxine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 207825
Ingredient-type | Analogs/Derivatives Vitamin B 6 |
Mechanism of Action | Histamine Receptor Antagonists |
Suppliers and Packaging for NDA: 207825
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 | 207825 | ANDA | Mylan Pharmaceuticals Inc. | 0378-4615 | 0378-4615-01 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-4615-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 10MG;10MG | ||||
Approval Date: | Jul 6, 2020 | TE: | AB | RLD: | No |
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