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. Forty 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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