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FDA Approval

Granisetron Hydrochloride

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Akorn
DUNS: 117693100
Effective Date
September 12, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Granisetron(1 mg in 1 mL)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Akorn

Akorn

117696832

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Granisetron Hydrochloride

Product Details

NDC Product Code
17478-546
Application Number
ANDA079078
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
May 23, 2022
Code: 318F6L70J8Class: ACTIMQuantity: 1 mg in 1 mL
Trisodium Citrate DihydrateInactive
Code: B22547B95KClass: IACT
Benzyl AlcoholInactive
Code: LKG8494WBHClass: IACT
Citric Acid MonohydrateInactive
Code: 2968PHW8QPClass: IACT
Sodium HydroxideInactive
Code: 55X04QC32IClass: IACT
Hydrochloric AcidInactive
Code: QTT17582CBClass: IACT
WaterInactive
Code: 059QF0KO0RClass: IACT
Sodium ChlorideInactive
Code: 451W47IQ8XClass: IACT
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