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Details for New Drug Application (NDA): 010721

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NDA 010721 describes ANTIVERT, which is a drug marketed by Casper Pharma Llc and is included in one NDA. It is available from one supplier. Additional details are available on the ANTIVERT profile page.

The generic ingredient in ANTIVERT 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: 010721

Casper Pharma Llc
meclizine hydrochloride
Therapeutic Class:Antiemetics

Pharmacology for NDA: 010721

Physiological EffectEmesis Suppression

Suppliers and Packaging for NDA: 010721

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
meclizine hydrochloride
TABLET, CHEWABLE;ORAL 010721 NDA Roerig 0049-2100 0049-2100-66 100 TABLET in 1 BOTTLE (0049-2100-66)
meclizine hydrochloride
TABLET, CHEWABLE;ORAL 010721 NDA Roerig 0049-2100 0049-2100-82 1000 TABLET in 1 BOTTLE (0049-2100-82)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Jan 20, 1982TE:AARLD:Yes

Summary for product number 004

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Approved Prior to Jan 1, 1982TE:AARLD:Yes

Summary for product number 005

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, CHEWABLE;ORALStrength25MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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