Details for New Drug Application (NDA): 087294
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The generic ingredient in HYDROXYZINE HYDROCHLORIDE is hydroxyzine hydrochloride. There are nineteen drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the hydroxyzine hydrochloride profile page.
Summary for 087294
Tradename: | HYDROXYZINE HYDROCHLORIDE |
Applicant: | Chartwell Rx |
Ingredient: | hydroxyzine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 087294
Mechanism of Action | Histamine Receptor Antagonists |
Suppliers and Packaging for NDA: 087294
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HYDROXYZINE HYDROCHLORIDE | hydroxyzine hydrochloride | SYRUP;ORAL | 087294 | ANDA | Chartwell RX, LLC | 62135-750 | 62135-750-47 | 473 mL in 1 BOTTLE (62135-750-47) |
HYDROXYZINE HYDROCHLORIDE | hydroxyzine hydrochloride | SYRUP;ORAL | 087294 | ANDA | Proficient Rx LP | 63187-494 | 63187-494-04 | 118 mL in 1 BOTTLE, PLASTIC (63187-494-04) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SYRUP;ORAL | Strength | 10MG/5ML | ||||
Approval Date: | Apr 12, 1982 | TE: | AA | RLD: | Yes |
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