Details for New Drug Application (NDA): 205136
✉ Email this page to a colleague
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 205136
Tradename: | MECLIZINE HYDROCHLORIDE |
Applicant: | Wilshire Pharms Inc |
Ingredient: | meclizine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 205136
Physiological Effect | Emesis Suppression |
Medical Subject Heading (MeSH) Categories for 205136
Suppliers and Packaging for NDA: 205136
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MECLIZINE HYDROCHLORIDE | meclizine hydrochloride | TABLET;ORAL | 205136 | ANDA | Wilshire Pharmaceuticals Inc | 52536-129 | 52536-129-01 | 100 TABLET in 1 BOTTLE (52536-129-01) |
MECLIZINE HYDROCHLORIDE | meclizine hydrochloride | TABLET;ORAL | 205136 | ANDA | Wilshire Pharmaceuticals Inc | 52536-129 | 52536-129-10 | 1000 TABLET in 1 BOTTLE (52536-129-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG | ||||
Approval Date: | Feb 22, 2019 | TE: | AA | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Feb 22, 2019 | TE: | AA | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Feb 22, 2019 | TE: | AA | RLD: | No |
Complete Access Available with Subscription