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… Robinul Forte (glycopyrrolate) Tablets, First Horizon Pharmaceutical NDA 12-827/S-049 7/25/03 8/6/03 Robinul & Robinul Forte (glycopyrrolate) Tablets, First Horizon Pharmaceutical NDA 17-558/S-049 7/25/03 Robinul (glycopyrrolate) Injectable, Baxter Healthcare NDA 17-558/S-047, S-048 GLYCOPYRROLATE Injection 0.2MG/ML ROBINUL Baxter CORP 089335 GLYCOPYRROLATE Injection 0.2MG/ML GLYCOPYRROLATE LUITPOLD 012827 GLYCOPYRROLATE Tablet; 1MG ROBINUL FIRST HORIZON 012827 GLYCOPYRROLATE Tablet; 2MG ROBINUL FORTE FIRST HORIZON   For the latest approval information, locate this drug using this index.