Details for New Drug Application (NDA): 204756
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NDA 204756 describes METOCLOPRAMIDE, which is a drug marketed by Avet Lifesciences, 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-five NDAs. It is available from three suppliers. Additional details are available on the METOCLOPRAMIDE profile page.
The generic ingredient in METOCLOPRAMIDE is metoclopramide hydrochloride. There are fourteen drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the metoclopramide hydrochloride profile page.
The generic ingredient in METOCLOPRAMIDE is metoclopramide hydrochloride. There are fourteen drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the metoclopramide hydrochloride profile page.
Summary for 204756
| Tradename: | METOCLOPRAMIDE |
| Applicant: | Avet Lifesciences |
| Ingredient: | metoclopramide hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 204756
| Mechanism of Action | Dopamine D2 Antagonists |
Medical Subject Heading (MeSH) Categories for 204756
Suppliers and Packaging for NDA: 204756
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| METOCLOPRAMIDE | metoclopramide hydrochloride | INJECTABLE;INJECTION | 204756 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-240 | 23155-240-41 | 25 VIAL in 1 CARTON (23155-240-41) / 2 mL in 1 VIAL (23155-240-31) |
| METOCLOPRAMIDE | metoclopramide hydrochloride | INJECTABLE;INJECTION | 204756 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-240 | 23155-240-42 | 25 VIAL in 1 CARTON (23155-240-42) / 10 mL in 1 VIAL (23155-240-32) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 5MG BASE/ML | ||||
| Approval Date: | Dec 20, 2013 | TE: | AP | RLD: | No | ||||
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