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Details for New Drug Application (NDA): 017862
The generic ingredient in REGLAN is metoclopramide hydrochloride. There are twelve drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the metoclopramide hydrochloride profile page.
Summary for 017862
Tradename: | REGLAN |
Applicant: | West-ward Pharms Int |
Ingredient: | metoclopramide hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 017862
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 5MG BASE/ML | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No |
Profile for product number 004
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 10MG BASE/ML | ||||
Approval Date: | May 28, 1987 | TE: | RLD: | No |
Expired US Patents for NDA 017862
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
West-ward Pharms Int | REGLAN | metoclopramide hydrochloride | INJECTABLE;INJECTION | 017862-001 | Approved Prior to Jan 1, 1982 | ➤ Sign Up | ➤ Sign Up |
West-ward Pharms Int | REGLAN | metoclopramide hydrochloride | INJECTABLE;INJECTION | 017862-004 | May 28, 1987 | ➤ Sign Up | ➤ Sign Up |
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
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