Details for New Drug Application (NDA): 071402
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The generic ingredient in METOCLOPRAMIDE HYDROCHLORIDE is metoclopramide hydrochloride. There are fourteen drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the metoclopramide hydrochloride profile page.
Summary for 071402
Tradename: | METOCLOPRAMIDE HYDROCHLORIDE |
Applicant: | Ani Pharms |
Ingredient: | metoclopramide hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 071402
Mechanism of Action | Dopamine D2 Antagonists |
Medical Subject Heading (MeSH) Categories for 071402
Suppliers and Packaging for NDA: 071402
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METOCLOPRAMIDE HYDROCHLORIDE | metoclopramide hydrochloride | SOLUTION;ORAL | 071402 | ANDA | ANI Pharmaceuticals, Inc. | 62559-190 | 62559-190-16 | 473 mL in 1 BOTTLE, PLASTIC (62559-190-16) |
METOCLOPRAMIDE HYDROCHLORIDE | metoclopramide hydrochloride | SOLUTION;ORAL | 071402 | ANDA | Bryant Ranch Prepack | 63629-1961 | 63629-1961-1 | 473 mL in 1 BOTTLE (63629-1961-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | EQ 5MG BASE/5ML | ||||
Approval Date: | Jun 25, 1993 | TE: | AA | RLD: | No |
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