ROTOP - DMSA
ROTOP – DMSA 1.0 mg
Approved
Approval ID
fa643e8a-a8d2-4868-92ad-98dd17e92172
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 9, 2021
Manufacturers
FDA
ROTOP Pharmaka GmbH
DUNS: 314666202
Products 1
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 Succimer Injection
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71647-001
Product Classification
G
Generic Name
Kit for the Preparation of Technetium Tc99m Succimer Injection
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 9, 2021
FDA Product Classification
INGREDIENTS (6)
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
NITROGENInactive
Code: N762921K75
Classification: IACT
2,3-DIMERCAPTOSUCCINIC ACIDActive
Quantity: 1 mg in 1 1
Code: 4S9JU7XF01
Classification: ACTIB
STANNOUS CHLORIDEInactive
Code: 1BQV3749L5
Classification: IACT