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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

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…

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 | Robinul (glycopyrrolate for injection, USP) Injection, Baxter Healthcare, Labeling Revision | Glycopyrrolate Tablets, CorePharma, Approval | Robinul (glycopyrrolate) Injection, Baxter Healthcare, Labeling Revision | Glycopyrrolate Tablets, Kali Laboratories, Approval | Glycopyrrolate Tablets, Indicus Pharma, Approval | Glycopyrrolate Tablets, Vintage Pharmaceuticals, Approval | Glycopyrrolate Tablets, West-ward Pharmaceutical Corp., Approval | Glycopyrrolate Tablets, Ranbaxy Laboratories Ltd., Approval | Cuvposa (glycopyrrolate) Oral Solution, Shionogi Pharma, Inc., Approval | Glycopyrrolate Injection, Hikma Farmaceutica, Approval | Glycopyrrolate Tablets, Boca Pharmacal, Inc., Approval | Glycopyrrolate, glycopyrrolate, Tablet; Oral, Nexgen Pharma, Approval | Cuvposa, glycopyrrolate, Solution; Oral, Merz Pharms, Labeling Revision

^ FDA's latest approval appears at the bottom of this list. ^



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