Details for New Drug Application (NDA): 202191
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NDA 202191 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 202191
| Tradename: | METOCLOPRAMIDE HYDROCHLORIDE |
| Applicant: | Novel Labs Inc |
| Ingredient: | metoclopramide hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 202191
| Mechanism of Action | Dopamine D2 Antagonists |
Medical Subject Heading (MeSH) Categories for 202191
Suppliers and Packaging for NDA: 202191
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| METOCLOPRAMIDE HYDROCHLORIDE | metoclopramide hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 202191 | ANDA | Lupin Pharmaceuticals,Inc. | 43386-580 | 43386-580-31 | 1 BLISTER PACK in 1 CARTON (43386-580-31) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
| METOCLOPRAMIDE HYDROCHLORIDE | metoclopramide hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 202191 | ANDA | Lupin Pharmaceuticals,Inc. | 43386-581 | 43386-581-31 | 1 BLISTER PACK in 1 CARTON (43386-581-31) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | Aug 15, 2014 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Aug 15, 2014 | TE: | RLD: | No | |||||
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