Details for New Drug Application (NDA): 203003
✉ Email this page to a colleague
NDA 203003 describes MECLIZINE HYDROCHLORIDE, which is a drug marketed by Invagen Pharms, Ivax Sub Teva Pharms, Nexgen Pharma Inc, Pliva, Abc Holding, Amneal Pharms, Anabolic, Ani Pharms, Aurobindo Pharma Usa, Bundy, Chartwell Rx, Epic Pharma Llc, Heritage, Jubilant Cadista, Kv Pharm, Rising, Sandoz, Sciegen Pharms, Senores Pharms, Strides Pharma Intl, Superpharm, UDL, Vangard, Watson Labs, and Zydus Lifesciences, and is included in thirty-seven NDAs. It is available from twenty-four suppliers. Additional details are available on the MECLIZINE HYDROCHLORIDE profile page.
The generic ingredient in MECLIZINE HYDROCHLORIDE is meclizine hydrochloride. There is one drug master file entry for this compound. Thirty suppliers are listed for this compound. Additional details are available on the meclizine hydrochloride profile page.
The generic ingredient in MECLIZINE HYDROCHLORIDE is meclizine hydrochloride. There is one drug master file entry for this compound. Thirty suppliers are listed for this compound. Additional details are available on the meclizine hydrochloride profile page.
Summary for 203003
| Tradename: | MECLIZINE HYDROCHLORIDE |
| Applicant: | Chartwell Rx |
| Ingredient: | meclizine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 203003
| Physiological Effect | Emesis Suppression |
Medical Subject Heading (MeSH) Categories for 203003
Suppliers and Packaging for NDA: 203003
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MECLIZINE HYDROCHLORIDE | meclizine hydrochloride | TABLET;ORAL | 203003 | ANDA | Chartwell RX, LLC | 62135-952 | 62135-952-90 | 90 TABLET, FILM COATED in 1 BOTTLE (62135-952-90) |
| MECLIZINE HYDROCHLORIDE | meclizine hydrochloride | TABLET;ORAL | 203003 | ANDA | Chartwell RX, LLC | 62135-953 | 62135-953-90 | 90 TABLET, FILM COATED in 1 BOTTLE (62135-953-90) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG | ||||
| Approval Date: | Aug 11, 2022 | TE: | AA | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Aug 11, 2022 | TE: | AA | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Aug 11, 2022 | TE: | AA | RLD: | No | ||||
Complete Access Available with Subscription
