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Details for New Drug Application (NDA): 202640

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NDA 202640 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: 202640

Mylan Pharms Inc
meclizine hydrochloride
Therapeutic Class:Antiemetics

Pharmacology for NDA: 202640

Physiological EffectEmesis Suppression

Suppliers and Packaging for NDA: 202640

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
meclizine hydrochloride
TABLET;ORAL 202640 ANDA Mylan Pharmaceuticals Inc. 0378-5485 0378-5485-10 1000 TABLET in 1 BOTTLE, PLASTIC (0378-5485-10)
meclizine hydrochloride
TABLET;ORAL 202640 ANDA Mylan Pharmaceuticals Inc. 0378-5485 0378-5485-77 90 TABLET in 1 BOTTLE, PLASTIC (0378-5485-77)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG
Approval Date:Sep 17, 2012TE:AARLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Sep 17, 2012TE:AARLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength50MG
Approval Date:Sep 17, 2012TE:RLD:No

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