Details for New Drug Application (NDA): 073680
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NDA 073680 describes METOCLOPRAMIDE HYDROCHLORIDE, which is a drug marketed by Bedford, Fresenius Kabi Usa, Hospira, Lyphomed, Norbrook, Smith And Nephew, Teva Pharms Usa, Actavis Mid Atlantic, Ani Pharms, Chartwell Molecular, Genus, Morton Grove, Paco, Pharmobedient Cnsltg, Roxane, Teva, Vistapharm, Novel Labs Inc, Aiping Pharm Inc, Chartwell Rx, Clonmel, Halsey, Impax Labs Inc, Interpharm, Ipca Labs Ltd, Mutual Pharm, Northstar Hlthcare, Par Pharm, Sandoz, Schering, Strides Pharma, Sun Pharm Industries, Superpharm, Usl Pharma, and Watson Labs, and is included in fifty-three NDAs. It is available from twenty-eight suppliers. Additional details are available on the METOCLOPRAMIDE HYDROCHLORIDE profile page.
The generic ingredient in METOCLOPRAMIDE HYDROCHLORIDE is metoclopramide hydrochloride. There are fourteen drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the metoclopramide hydrochloride profile page.
The generic ingredient in METOCLOPRAMIDE HYDROCHLORIDE is metoclopramide hydrochloride. There are fourteen drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the metoclopramide hydrochloride profile page.
Summary for 073680
| Tradename: | METOCLOPRAMIDE HYDROCHLORIDE |
| Applicant: | Chartwell Molecular |
| Ingredient: | metoclopramide hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 073680
| Mechanism of Action | Dopamine D2 Antagonists |
Medical Subject Heading (MeSH) Categories for 073680
Suppliers and Packaging for NDA: 073680
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| METOCLOPRAMIDE HYDROCHLORIDE | metoclopramide hydrochloride | SOLUTION;ORAL | 073680 | ANDA | Chartwell RX, LLC | 62135-526 | 62135-526-24 | 2 TRAY in 1 BOX (62135-526-24) / 10 CUP in 1 TRAY / 10 mL in 1 CUP (62135-526-10) |
| METOCLOPRAMIDE HYDROCHLORIDE | metoclopramide hydrochloride | SOLUTION;ORAL | 073680 | ANDA | Chartwell RX, LLC | 62135-526 | 62135-526-47 | 473 mL in 1 BOTTLE (62135-526-47) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;ORAL | Strength | EQ 5MG BASE/5ML | ||||
| Approval Date: | Oct 27, 1992 | TE: | RLD: | No | |||||
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