Details for New Drug Application (NDA): 201094
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The generic ingredient in GLYDO is lidocaine hydrochloride. There are twenty-nine drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the lidocaine hydrochloride profile page.
Summary for 201094
Tradename: | GLYDO |
Applicant: | Sagent Pharms Inc |
Ingredient: | lidocaine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 201094
Physiological Effect | Local Anesthesia |
Suppliers and Packaging for NDA: 201094
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GLYDO | lidocaine hydrochloride | JELLY;TOPICAL | 201094 | ANDA | Sagent Pharmaceuticals | 25021-673 | 25021-673-76 | 10 SYRINGE in 1 CARTON (25021-673-76) / 6 mL in 1 SYRINGE |
GLYDO | lidocaine hydrochloride | JELLY;TOPICAL | 201094 | ANDA | Sagent Pharmaceuticals | 25021-673 | 25021-673-77 | 10 SYRINGE in 1 CARTON (25021-673-77) / 11 mL in 1 SYRINGE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | JELLY;TOPICAL | Strength | 2% | ||||
Approval Date: | Apr 28, 2014 | TE: | AT | RLD: | No |
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