Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Safety Information For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

FDA Approval Activities for this Drug… Metoclopramide Solution USP, 5 mg/5 mL, UDL , ANDA 75-051 Reglan (metoclopramide) Tablets, Injection, and Syrup, A.H. Robins c/o: Wyeth-Ayerst Research Reglan (metoclopramide, USP) Tablets, Schwartz Pharma, Labeling Revision | NDA 17-854/S-041, & 17-862/S-048, & 18-821/S-020 11/7/01 11/25/02 | Reglan (metoclopramide) Tablets, Schwartz Pharma, NDA 17-854/S-040 4/22/03 | Reglan (metoclopramide) Tablets, Injection, & Syrup, Wyeth-Ayerst NDA 17-854/S039, 17-862/S042, & 18-821/S018 Reglan (metoclopramide) Injection, Baxter Healthcare | Metoclopramide Orally Disintegrating Tablets, Schwarz Pharma, Approval | Metoclopramide Tablets, Vintage Pharmaceuticals, Approval | Metoclopramide Tablets, Northstar Healthcare, Approval | Metoclopramide Hydrochloride Tablets, Ipca Laboratories, Ltd., Approval | METOZOLV ODT (metoclopramide hydrochloride) Orally Disintegrating Tablets, Wilmington Pharmaceuticals, Approval | Reglan ODT (metoclopramide) Orally Disintegrating Tablets, Alaven Pharmaceuticals, Labeling Revision | Reglan (metoclopramide hydrochloride) Tablet, Baxter Healthcare Corp., Labeling Revision | Reglan ODT (metoclopramide hydrochloride) Orally Disintegrating Tablets, Alaven Pharmaceutical, Labeling Revision | Reglan (metoclopramide) Orally Disintegrating Tablet, Alaven Pharmaceutical, Labeling Revision | Reglan (metoclopramide hydrochloride) Tablets, ANI Pharmaceuticals, Inc., Labeling Revision | Reglan ODT (metoclopramide hydrochloride) Orally Disintegrating Tablets, Meda Pharmaceuticals, Inc., Labeling Revision | Metozolv ODT (metoclopramide) Orally Disintegrating Tablets, Salix Pharmaceuticals, Inc., Supplement | Metozolv ODT (metoclopramide) Orally Disintegrating Tablets, Salix Pharmaceuticals, Inc., Labeling Revision | Reglan (metoclopramide hydrochloride) Tablets, ANI Pharmaceuticals, Inc., Labeling Revision | Metozolv ODT (metoclopramide hydrochloride) Orally Disintegrating Tablets, Salix Pharmaceuticals, Inc., Labeling Revision | Reglan ODT (metoclopramide hydrochloride) Orally Disintegrating Tablets, Meda Pharmaceuticals, Inc., Labeling Revision | Reglan (metoclopramide) Orally Disintegrating Tablets, Meda Pharmaceuticals Inc., Labeling Revision ^ FDA's latest approval appears at the bottom of this list. ^                                                                       A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | For Industry | DMF Index | Pharma Job Search | Pharma Company News | Best Phone © 2012 Betterchem.com