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Details for New Drug Application (NDA): 089113

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NDA 089113 describes MECLIZINE HYDROCHLORIDE, which is a drug marketed by Superpharm, Vangard, Kv Pharm, Par Pharm, Pliva, Mylan Pharms Inc, Watson Labs, Sandoz, Amneal Pharms, Abc Holding, UDL, Ani Pharms Inc, Jubilant Cadista, Bundy, Ivax Sub Teva Pharms, Rising Pharms Inc, Anabolic, Nexgen Pharma Inc, and Epic Pharma Llc, and is included in thirty-four NDAs. It is available from forty suppliers. Additional details are available on the MECLIZINE HYDROCHLORIDE profile page.

The generic ingredient in MECLIZINE HYDROCHLORIDE is meclizine hydrochloride. There are seventeen drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the meclizine hydrochloride profile page.

Summary for NDA: 089113

Tradename:
MECLIZINE HYDROCHLORIDE
Applicant:
Superpharm
Ingredient:
meclizine hydrochloride
Patents:0
Therapeutic Class:Antiemetics
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength12.5MG
Approval Date:Aug 20, 1985TE:RLD:No


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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