Details for New Drug Application (NDA): 213957
✉ 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-seven suppliers are listed for this compound. Additional details are available on the meclizine hydrochloride profile page.
Summary for 213957
Tradename: | MECLIZINE HYDROCHLORIDE |
Applicant: | Zydus |
Ingredient: | meclizine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 213957
Physiological Effect | Emesis Suppression |
Medical Subject Heading (MeSH) Categories for 213957
Suppliers and Packaging for NDA: 213957
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MECLIZINE HYDROCHLORIDE | meclizine hydrochloride | TABLET;ORAL | 213957 | ANDA | A-S Medication Solutions | 50090-5727 | 50090-5727-2 | 12 TABLET in 1 BOTTLE (50090-5727-2) |
MECLIZINE HYDROCHLORIDE | meclizine hydrochloride | TABLET;ORAL | 213957 | ANDA | A-S Medication Solutions | 50090-5728 | 50090-5728-0 | 20 TABLET in 1 BOTTLE (50090-5728-0) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG | ||||
Approval Date: | Jun 23, 2020 | TE: | AA | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Jun 23, 2020 | TE: | AA | RLD: | No |
Complete Access Available with Subscription