Details for New Drug Application (NDA): 091392
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NDA 091392 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-nine 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-two 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-two suppliers are listed for this compound. Additional details are available on the metoclopramide hydrochloride profile page.
Summary for 091392
| Tradename: | METOCLOPRAMIDE HYDROCHLORIDE |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | metoclopramide hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 091392
| Mechanism of Action | Dopamine D2 Antagonists |
Medical Subject Heading (MeSH) Categories for 091392
Suppliers and Packaging for NDA: 091392
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| METOCLOPRAMIDE HYDROCHLORIDE | metoclopramide hydrochloride | INJECTABLE;INJECTION | 091392 | ANDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1367 | 51662-1367-1 | 1 SYRINGE, GLASS in 1 BLISTER PACK (51662-1367-1) / 2 mL in 1 SYRINGE, GLASS |
| METOCLOPRAMIDE HYDROCHLORIDE | metoclopramide hydrochloride | INJECTABLE;INJECTION | 091392 | ANDA | Fresenius Kabi USA, LLC | 76045-101 | 76045-101-20 | 24 BLISTER PACK in 1 CARTON (76045-101-20) / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-101-00) / 2 mL in 1 SYRINGE, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 5MG BASE/ML | ||||
| Approval Date: | Apr 19, 2013 | TE: | AP | RLD: | No | ||||
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