Details for New Drug Application (NDA): 202640
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NDA 202640 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 202640
| Tradename: | MECLIZINE HYDROCHLORIDE |
| Applicant: | Aurobindo Pharma Usa |
| Ingredient: | meclizine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 202640
| Physiological Effect | Emesis Suppression |
Medical Subject Heading (MeSH) Categories for 202640
Suppliers and Packaging for NDA: 202640
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MECLIZINE HYDROCHLORIDE | meclizine hydrochloride | TABLET;ORAL | 202640 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8514 | 0615-8514-39 | 30 TABLET in 1 BLISTER PACK (0615-8514-39) |
| MECLIZINE HYDROCHLORIDE | meclizine hydrochloride | TABLET;ORAL | 202640 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8515 | 0615-8515-39 | 30 TABLET in 1 BLISTER PACK (0615-8515-39) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG | ||||
| Approval Date: | Sep 17, 2012 | TE: | AA | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Sep 17, 2012 | TE: | AA | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Sep 17, 2012 | TE: | AA | RLD: | No | ||||
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