Details for New Drug Application (NDA): 217652
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NDA 217652 describes HYDROXYZINE HYDROCHLORIDE, which is a drug marketed by Altana, Am Regent, Baxter Hlthcare, Dr Reddys, Fresenius Kabi Usa, Hospira, Pharmafair, Smith And Nephew, Solopak, Watson Labs, Wyeth Ayerst, Alpharma Us Pharms, Anima, Apozeal Pharms, Chartwell Rx, Hikma, Kv Pharm, Lannett Co Inc, Pai Holdings Pharm, Able, Actavis Elizabeth, Amneal Pharm, Aurobindo Pharma Ltd, Epic Pharma Llc, Graviti Pharms, Halsey, Heritage Pharma, Hetero Labs Ltd Iii, Invagen Pharms, Ivax Pharms, Kvk Tech, Mutual Pharm, Northstar Hlthcare, Nuvo Pharms Inc, Pliva, Prinston Inc, Purepac Pharm, Quantum Pharmics, Rising, Sandoz, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Industries, Superpharm, and Usl Pharma, and is included in one hundred NDAs. It is available from forty-six suppliers. Additional details are available on the HYDROXYZINE HYDROCHLORIDE profile page.
The generic ingredient in HYDROXYZINE HYDROCHLORIDE is hydroxyzine hydrochloride. There are nineteen drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the hydroxyzine hydrochloride profile page.
The generic ingredient in HYDROXYZINE HYDROCHLORIDE is hydroxyzine hydrochloride. There are nineteen drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the hydroxyzine hydrochloride profile page.
Summary for 217652
| Tradename: | HYDROXYZINE HYDROCHLORIDE |
| Applicant: | Graviti Pharms |
| Ingredient: | hydroxyzine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 217652
| Mechanism of Action | Histamine Receptor Antagonists |
Suppliers and Packaging for NDA: 217652
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HYDROXYZINE HYDROCHLORIDE | hydroxyzine hydrochloride | TABLET;ORAL | 217652 | ANDA | Rising Pharma Holdings, Inc. | 16571-113 | 16571-113-01 | 100 TABLET, FILM COATED in 1 BOTTLE (16571-113-01) |
| HYDROXYZINE HYDROCHLORIDE | hydroxyzine hydrochloride | TABLET;ORAL | 217652 | ANDA | Rising Pharma Holdings, Inc. | 16571-113 | 16571-113-50 | 500 TABLET, FILM COATED in 1 BOTTLE (16571-113-50) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Aug 17, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Aug 17, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Aug 17, 2023 | TE: | AB | RLD: | No | ||||
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