Details for New Drug Application (NDA): 072215
NDA 072215 describes METOCLOPRAMIDE HYDROCHLORIDE, which is a drug marketed by Baxter Hlthcare Corp, Bedford, Fresenius Kabi Usa, Hospira, Lyphomed, Norbrook, Smith And Nephew, Teva Pharms Usa, Actavis Mid Atlantic, Ani Pharms, Chartwell Molecular, Morton Grove, Paco, Pai Holdings, Pharmobedient Cnsltg, Roxane, Teva, Vistapharm Llc, 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 Intl, Sun Pharm Industries, Superpharm, Usl Pharma, and Watson Labs, and is included in fifty-four NDAs. It is available from thirty-six suppliers. Additional details are available on the METOCLOPRAMIDE HYDROCHLORIDE profile page.
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.
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 072215
| Tradename: | METOCLOPRAMIDE HYDROCHLORIDE |
| Applicant: | Aiping Pharm Inc |
| Ingredient: | metoclopramide hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 072215
| Mechanism of Action | Dopamine D2 Antagonists |
Medical Subject Heading (MeSH) Categories for 072215
Suppliers and Packaging for NDA: 072215
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| METOCLOPRAMIDE HYDROCHLORIDE | metoclopramide hydrochloride | TABLET;ORAL | 072215 | ANDA | ScieGen Pharmaceuticals, Inc. | 50228-232 | 50228-232-01 | 100 TABLET in 1 BOTTLE (50228-232-01) |
| METOCLOPRAMIDE HYDROCHLORIDE | metoclopramide hydrochloride | TABLET;ORAL | 072215 | ANDA | ScieGen Pharmaceuticals, Inc. | 50228-232 | 50228-232-05 | 500 TABLET in 1 BOTTLE (50228-232-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Jan 30, 1990 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | Nov 5, 2024 | TE: | AB | RLD: | No | ||||
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