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FDA Approval

glydo

CompanySagent Pharmaceuticals (DUNS: 796852890)

Effective Date

January 31, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Lidocaine Hydrochloride/Bupivacaine Hydrochloride(20 mg in 1 mL)

Products (1)

glydo

NDC Product Code

25021-673

Application Number

ANDA201094

Marketing Category

ANDA (C73584)

Route of Administration

TOPICAL

Effective Date

January 31, 2022

Ingredients

hypromellosesInactive

Code: 3NXW29V3WOClass: IACT

sodium hydroxideInactive

Code: 55X04QC32IClass: IACT

Lidocaine Hydrochloride/Bupivacaine HydrochlorideActive

Code: EC2CNF7XFPClass: ACTIBQuantity: 20 mg in 1 mL

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