Details for New Drug Application (NDA): 203003
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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, Apnar Pharma Lp, Aurobindo Pharma Usa, Bundy, Chartwell Rx, Epic Pharma Llc, Heritage, Jubilant Cadista, Kv Pharm, Rising, Sandoz, Sciegen Pharms Inc, Strides Pharma Intl, Superpharm, UDL, Vangard, Watson Labs, and Zydus Lifesciences, and is included in thirty-seven NDAs. It is available from twenty-five suppliers. Additional details are available on the MECLIZINE HYDROCHLORIDE profile page.
The generic ingredient in MECLIZINE HYDROCHLORIDE is meclizine hydrochloride. There are seventeen drug master file entries for this compound. Thirty-one 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 are seventeen drug master file entries for this compound. Thirty-one 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 | ||||
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