Details for New Drug Application (NDA): 010721
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NDA 010721 describes ANTIVERT, which is a drug marketed by Casper Pharma Llc and is included in one NDA. It is available from eleven suppliers. Additional details are available on the ANTIVERT profile page.
The generic ingredient in ANTIVERT is meclizine hydrochloride. There are seventeen drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the meclizine hydrochloride profile page.
The generic ingredient in ANTIVERT is meclizine hydrochloride. There are seventeen drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the meclizine hydrochloride profile page.
Summary for 010721
| Tradename: | ANTIVERT |
| Applicant: | Casper Pharma Llc |
| Ingredient: | meclizine hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 010721
Suppliers and Packaging for NDA: 010721
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ANTIVERT | meclizine hydrochloride | TABLET, CHEWABLE;ORAL | 010721 | NDA AUTHORIZED GENERIC | Rising Pharma Holdings, Inc. | 16571-660 | 16571-660-01 | 100 TABLET in 1 BOTTLE (16571-660-01) |
| ANTIVERT | meclizine hydrochloride | TABLET, CHEWABLE;ORAL | 010721 | NDA AUTHORIZED GENERIC | Rising Pharma Holdings, Inc. | 16571-660 | 16571-660-50 | 500 TABLET in 1 BOTTLE (16571-660-50) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jan 20, 1982 | TE: | AA | RLD: | Yes | ||||
Profile for product number 004
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AA | RLD: | Yes | ||||
Profile for product number 005
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, CHEWABLE;ORAL | Strength | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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