Details for New Drug Application (NDA): 072744
The generic ingredient in METOCLOPRAMIDE HYDROCHLORIDE is metoclopramide hydrochloride. There is one drug master file entry for this compound. Forty suppliers are listed for this compound. Additional details are available on the metoclopramide hydrochloride profile page.
Summary for 072744
| Tradename: | METOCLOPRAMIDE HYDROCHLORIDE |
| Applicant: | Pai Holdings |
| Ingredient: | metoclopramide hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 072744
| Mechanism of Action | Dopamine D2 Antagonists |
Medical Subject Heading (MeSH) Categories for 072744
Suppliers and Packaging for NDA: 072744
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| METOCLOPRAMIDE HYDROCHLORIDE | metoclopramide hydrochloride | SOLUTION;ORAL | 072744 | ANDA | PAI Holdings, LLC dba PAI Pharma | 0121-0576 | 0121-0576-16 | 473 mL in 1 BOTTLE (0121-0576-16) |
| METOCLOPRAMIDE HYDROCHLORIDE | metoclopramide hydrochloride | SOLUTION;ORAL | 072744 | ANDA | PAI Holdings, LLC dba PAI Pharma | 0121-1576 | 0121-1576-10 | 10 TRAY in 1 CASE (0121-1576-10) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | EQ 5MG BASE/5ML | ||||
| Approval Date: | May 28, 1991 | TE: | AA | RLD: | No | ||||
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