Details for New Drug Application (NDA): 084657
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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 084657
Tradename: | MECLIZINE HYDROCHLORIDE |
Applicant: | Ani Pharms |
Ingredient: | meclizine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 084657
Physiological Effect | Emesis Suppression |
Medical Subject Heading (MeSH) Categories for 084657
Suppliers and Packaging for NDA: 084657
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MECLIZINE HYDROCHLORIDE | meclizine hydrochloride | TABLET;ORAL | 084657 | ANDA | St. Mary's Medical Park Pharmacy | 60760-842 | 60760-842-30 | 30 TABLET in 1 BOTTLE, PLASTIC (60760-842-30) |
MECLIZINE HYDROCHLORIDE | meclizine hydrochloride | TABLET;ORAL | 084657 | ANDA | Redpharm Drug, Inc. | 67296-1849 | 67296-1849-3 | 30 TABLET in 1 BOTTLE (67296-1849-3) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 12.5MG | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No |
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