Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Sun Pharmaceutical Industries, Inc.
139261648
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Sun Pharmaceutical Industries, Inc.
Sun Pharmaceutical Industries, Inc.
Sun Pharmaceutical Industries, Inc.
139261648
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Kit for the Preparation of Technetium Tc99m Sestamibi
Product Details
NDC Product Code
45567-0555Application Number
ANDA079157Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
March 31, 2020CYSTEINE HYDROCHLORIDEInactive
Code: ZT934N0X4WClass: IACTQuantity: 1 mg in 10 mL
Code: 971Z4W1S09Class: ACTIBQuantity: 1 mg in 10 mL
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95KClass: IACTQuantity: 2.6 mg in 10 mL
STANNOUS CHLORIDEInactive
Code: 1BQV3749L5Class: IACTQuantity: 0.075 mg in 10 mL
MANNITOLInactive
Code: 3OWL53L36AClass: IACTQuantity: 20 mg in 10 mL