Details for New Drug Application (NDA): 202640
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The generic ingredient in MECLIZINE HYDROCHLORIDE is meclizine hydrochloride. There are seventeen drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the meclizine hydrochloride profile page.
Summary for 202640
Tradename: | MECLIZINE HYDROCHLORIDE |
Applicant: | Aurobindo Pharma Usa |
Ingredient: | meclizine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 202640
Physiological Effect | Emesis Suppression |
Medical Subject Heading (MeSH) Categories for 202640
Suppliers and Packaging for NDA: 202640
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MECLIZINE HYDROCHLORIDE | meclizine hydrochloride | TABLET;ORAL | 202640 | ANDA | Aurobindo Pharma Limited | 59651-807 | 59651-807-01 | 100 TABLET in 1 BOTTLE (59651-807-01) |
MECLIZINE HYDROCHLORIDE | meclizine hydrochloride | TABLET;ORAL | 202640 | ANDA | Aurobindo Pharma Limited | 59651-807 | 59651-807-99 | 1000 TABLET in 1 BOTTLE (59651-807-99) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG | ||||
Approval Date: | Sep 17, 2012 | TE: | AA | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Sep 17, 2012 | TE: | AA | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Sep 17, 2012 | TE: | AA | RLD: | No |
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