Details for New Drug Application (NDA): 018821
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NDA 018821 describes REGLAN, which is a drug marketed by Hikma, Robins Ah, Ani Pharms, and Meda Pharms, and is included in four NDAs. It is available from three suppliers. Additional details are available on the REGLAN profile page.
The generic ingredient in REGLAN is metoclopramide hydrochloride. There are fourteen drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the metoclopramide hydrochloride profile page.
The generic ingredient in REGLAN is metoclopramide hydrochloride. There are fourteen drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the metoclopramide hydrochloride profile page.
Summary for 018821
| Tradename: | REGLAN |
| Applicant: | Robins Ah |
| Ingredient: | metoclopramide hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 018821
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;ORAL | Strength | EQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Mar 25, 1983 | TE: | RLD: | Yes | |||||
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