Lanreotide Acetate
These highlights do not include all the information needed to use LANREOTIDE INJECTION safely and effectively. See full prescribing information for LANREOTIDE INJECTION. LANREOTIDE injection, for subcutaneous useInitial U.S. Approval: 2007
Approved
Approval ID
11da176a-99bc-4ada-8b3f-6bd2b37a6313
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 1, 2023
Manufacturers
FDA
Cipla USA Inc.
DUNS: 078719707
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
lanreotide acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69097-890
Application NumberNDA215395
Product Classification
M
Marketing Category
C73594
G
Generic Name
lanreotide acetate
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateSeptember 1, 2023
FDA Product Classification
INGREDIENTS (1)
LANREOTIDE ACETATEActive
Quantity: 90 mg in 0.3 mL
Code: IEU56G3J9C
Classification: ACTIM
lanreotide acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69097-880
Application NumberNDA215395
Product Classification
M
Marketing Category
C73594
G
Generic Name
lanreotide acetate
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateSeptember 1, 2023
FDA Product Classification
INGREDIENTS (1)
LANREOTIDE ACETATEActive
Quantity: 60 mg in 0.2 mL
Code: IEU56G3J9C
Classification: ACTIM
lanreotide acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69097-870
Application NumberNDA215395
Product Classification
M
Marketing Category
C73594
G
Generic Name
lanreotide acetate
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateSeptember 1, 2023
FDA Product Classification
INGREDIENTS (1)
LANREOTIDE ACETATEActive
Quantity: 120 mg in 0.5 mL
Code: IEU56G3J9C
Classification: ACTIM