Key Data Files for this Active Pharmaceutical Ingredient:

Drug Master Files, 21 CFR, and other industry portals Patent/Exclusivity data file Drug Approval Drug Safety Freedom of Information Federal Register pages Pharma Companies Pharmacopeial Information Preferred API Supplier (Clients Only)

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   For the latest approval information, locate this drug using this index.