Details for New Drug Application (NDA): 017854
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NDA 017854 describes REGLAN, which is a drug marketed by Hikma, Robins Ah, Ani Pharms, and Meda Pharms, and is included in four NDAs. It is available from one supplier. Additional details are available on the REGLAN profile page.
The generic ingredient in REGLAN 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 REGLAN 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 017854
| Tradename: | REGLAN |
| Applicant: | Ani Pharms |
| Ingredient: | metoclopramide hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 017854
| Mechanism of Action | Dopamine D2 Antagonists |
Medical Subject Heading (MeSH) Categories for 017854
Suppliers and Packaging for NDA: 017854
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| REGLAN | metoclopramide hydrochloride | TABLET;ORAL | 017854 | NDA | ANI Pharmaceuticals, Inc. | 62559-165 | 62559-165-01 | 100 TABLET in 1 BOTTLE, PLASTIC (62559-165-01) |
| REGLAN | metoclopramide hydrochloride | TABLET;ORAL | 017854 | NDA | ANI Pharmaceuticals, Inc. | 62559-166 | 62559-166-01 | 100 TABLET in 1 BOTTLE, PLASTIC (62559-166-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | May 5, 1987 | TE: | AB | RLD: | Yes | ||||
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