Katerzia
These highlights do not include all the information needed to use KATERZIA safely and effectively. See full prescribing information for KATERZIA. Initial U.S. Approval: 1992
Approved
Approval ID
df673a4d-acb8-444c-a472-c87ab8cbd366
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 28, 2023
Manufacturers
FDA
Azurity Pharmaceuticals, Inc.
DUNS: 117505635
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Amlodipine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52652-5001
Application NumberNDA211340
Product Classification
M
Marketing Category
C73594
G
Generic Name
Amlodipine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 28, 2020
FDA Product Classification
INGREDIENTS (10)
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
Amlodipine BenzoateActive
Quantity: 1 mg in 1 mL
Code: XD75TQ8A2P
Classification: ACTIM
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT