Clobazam
These highlights do not include all the information needed to use CLOBAZAM ORAL SUSPENSION safely and effectively. See full prescribing information for CLOBAZAM ORAL SUSPENSION. CLOBAZAM oral suspension, CIV Initial U.S. Approval: 2011
Approved
Approval ID
1b5749a1-1c6d-4243-a833-4bfd84f9d5a9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 26, 2023
Manufacturers
FDA
Aurobindo Pharma Limited
DUNS: 650082092
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Clobazam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59651-401
Application NumberANDA214404
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clobazam
Product Specifications
Route of AdministrationORAL
Effective DateMay 26, 2023
FDA Product Classification
INGREDIENTS (16)
STRAWBERRYInactive
Code: 4J2TY8Y81V
Classification: IACT
CLOBAZAMActive
Quantity: 2.5 mg in 1 mL
Code: 2MRO291B4U
Classification: ACTIB
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Code: 94255I6E2T
Classification: IACT
MALTITOLInactive
Code: D65DG142WK
Classification: IACT
MAGNESIUM ALUMINUM SILICATE TYPE IIAInactive
Code: II0CAA4909
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)Inactive
Code: 461P5CJN6T
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT