Details for New Drug Application (NDA): 200294
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NDA 200294 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, Invatech, Jubilant Cadista, Kv Pharm, Rising, Sandoz, Strides Pharma, Superpharm, UDL, Vangard, Watson Labs, and Zydus Lifesciences, and is included in thirty-seven NDAs. It is available from twenty-eight 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-three 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-three suppliers are listed for this compound. Additional details are available on the meclizine hydrochloride profile page.
Summary for 200294
| Tradename: | MECLIZINE HYDROCHLORIDE |
| Applicant: | Epic Pharma Llc |
| Ingredient: | meclizine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 200294
| Physiological Effect | Emesis Suppression |
Medical Subject Heading (MeSH) Categories for 200294
Suppliers and Packaging for NDA: 200294
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MECLIZINE HYDROCHLORIDE | meclizine hydrochloride | TABLET;ORAL | 200294 | ANDA | Epic Pharma LLC | 42806-012 | 42806-012-01 | 100 TABLET in 1 BOTTLE (42806-012-01) |
| MECLIZINE HYDROCHLORIDE | meclizine hydrochloride | TABLET;ORAL | 200294 | ANDA | Epic Pharma LLC | 42806-012 | 42806-012-10 | 1000 TABLET in 1 BOTTLE (42806-012-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG | ||||
| Approval Date: | Apr 13, 2012 | TE: | AA | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Apr 13, 2012 | TE: | AA | RLD: | No | ||||
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