Humatin
Rx Only
Approved
Approval ID
a725f022-ec3c-430d-8021-96c861b9893c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 10, 2023
Manufacturers
FDA
Waylis Therapeutics LLC
DUNS: 117678921
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PAROMOMYCIN SULFATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code80725-250
Application NumberANDA065173
Product Classification
M
Marketing Category
C73584
G
Generic Name
PAROMOMYCIN SULFATE
Product Specifications
Route of AdministrationORAL
Effective DateMarch 26, 2021
FDA Product Classification
INGREDIENTS (11)
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
PAROMOMYCIN SULFATEActive
Quantity: 250 mg in 1 1
Code: 845NU6GJPS
Classification: ACTIB
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT