Details for New Drug Application (NDA): 201451
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The generic ingredient in MECLIZINE HYDROCHLORIDE is meclizine hydrochloride. There are seventeen drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the meclizine hydrochloride profile page.
Summary for 201451
Tradename: | MECLIZINE HYDROCHLORIDE |
Applicant: | Amneal Pharms |
Ingredient: | meclizine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 201451
Physiological Effect | Emesis Suppression |
Medical Subject Heading (MeSH) Categories for 201451
Suppliers and Packaging for NDA: 201451
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MECLIZINE HYDROCHLORIDE | meclizine hydrochloride | TABLET;ORAL | 201451 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8462 | 0615-8462-39 | 30 TABLET in 1 BLISTER PACK (0615-8462-39) |
MECLIZINE HYDROCHLORIDE | meclizine hydrochloride | TABLET;ORAL | 201451 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8488 | 0615-8488-39 | 30 TABLET in 1 BLISTER PACK (0615-8488-39) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG | ||||
Approval Date: | Feb 23, 2011 | TE: | AA | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Feb 23, 2011 | TE: | AA | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Feb 23, 2011 | TE: | AA | RLD: | No |
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