Hydroxyzine hydrochloride - Generic Drug Details
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What are the generic drug sources for hydroxyzine hydrochloride and what is the scope of freedom to operate?
Hydroxyzine hydrochloride
is the generic ingredient in five branded drugs marketed by Baxter Hlthcare, Altana, Am Regent, Dr Reddys, Fresenius Kabi Usa, Hospira, Pharmafair, Smith And Nephew, Solopak, Watson Labs, Wyeth Ayerst, Organon Usa Inc, Pfizer, Roerig, 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 and four NDAs. Additional information is available in the individual branded drug profile pages.There are seven drug master file entries for hydroxyzine hydrochloride. Forty-seven suppliers are listed for this compound.
Summary for hydroxyzine hydrochloride
US Patents: | 0 |
Tradenames: | 5 |
Applicants: | 48 |
NDAs: | 104 |
Drug Master File Entries: | 7 |
Finished Product Suppliers / Packagers: | 47 |
Raw Ingredient (Bulk) Api Vendors: | 204 |
Clinical Trials: | 33 |
Patent Applications: | 6,837 |
What excipients (inactive ingredients) are in hydroxyzine hydrochloride? | hydroxyzine hydrochloride excipients list |
DailyMed Link: | hydroxyzine hydrochloride at DailyMed |
Recent Clinical Trials for hydroxyzine hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Sultan Qaboos University | Phase 4 |
The S.N. Fyodorov Eye Microsurgery State Institution | Early Phase 1 |
Minia University | Phase 1 |
Pharmacology for hydroxyzine hydrochloride
Drug Class | Antihistamine |
Mechanism of Action | Histamine Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for hydroxyzine hydrochloride
US Patents and Regulatory Information for hydroxyzine hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Pfizer | VISTARIL | hydroxyzine hydrochloride | INJECTABLE;INJECTION | 011111-002 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Northstar Hlthcare | HYDROXYZINE HYDROCHLORIDE | hydroxyzine hydrochloride | TABLET;ORAL | 040840-003 | Mar 31, 2008 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
Lannett Co Inc | HYDROXYZINE HYDROCHLORIDE | hydroxyzine hydrochloride | SYRUP;ORAL | 201674-001 | Aug 21, 2013 | AA | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
Hospira | HYDROXYZINE HYDROCHLORIDE | hydroxyzine hydrochloride | INJECTABLE;INJECTION | 087416-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
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Hydroxyzine hydrochloride Market Analysis and Financial Projection Experimental
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