FDA NDA 201094, GLYDO, SAGENT PHARMS INC, 04/28/2014

Contents: Summary Basis of Approval (SBOA) of GLYDO (Lidocaine Hydrochloride) jelly 2% held by Sagent Pharmaceuticals INC.

NDA: 201094
Company: SAGENT PHARMS INC
Drug Name: GLYDO
Active Ingredients: LIDOCAINE HYDROCHLORIDE
Strength: 2%
Dosage Form/Route: JELLY;TOPICAL
Action Date: 04/28/2014
Marketing Status: Prescription
Submission Classification: ORIG-1
Action Date:  04/28/2014

273 Pages

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