Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Wockhardt USA LLC.
170508365
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Wockhardt Limited
Wockhardt USA LLC.
Wockhardt USA LLC.
676257570
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
64679-662Application Number
ANDA078566Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
November 28, 2019GranisetronActive
Code: 318F6L70J8Class: ACTIMQuantity: 0.1 mg in 1 mL
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT