Details for New Drug Application (NDA): 205136
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NDA 205136 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 205136
| Tradename: | MECLIZINE HYDROCHLORIDE |
| Applicant: | Heritage |
| Ingredient: | meclizine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 205136
| Physiological Effect | Emesis Suppression |
Medical Subject Heading (MeSH) Categories for 205136
Suppliers and Packaging for NDA: 205136
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MECLIZINE HYDROCHLORIDE | meclizine hydrochloride | TABLET;ORAL | 205136 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-943 | 23155-943-01 | 100 TABLET in 1 BOTTLE (23155-943-01) |
| MECLIZINE HYDROCHLORIDE | meclizine hydrochloride | TABLET;ORAL | 205136 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-943 | 23155-943-10 | 1000 TABLET in 1 PACKAGE (23155-943-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 12.5MG | ||||
| Approval Date: | Feb 22, 2019 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Feb 22, 2019 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Feb 22, 2019 | TE: | AA | RLD: | No | ||||
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