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KLONOPIN

Approved
Approval ID

bda569c3-106c-41c1-913c-6f6e8e60bfd4

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 22, 2011

Manufacturers
FDA

STAT RX USA LLC

DUNS: 786036330

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

CLONAZEPAM

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code16590-935
Application NumberNDA017533
Product Classification
M
Marketing Category
C73594
G
Generic Name
CLONAZEPAM
Product Specifications
Route of AdministrationORAL
Effective DateMarch 22, 2011
FDA Product Classification

INGREDIENTS (8)

CLONAZEPAMActive
Quantity: 1 mg in 1 1
Code: 5PE9FDE8GB
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT

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KLONOPIN - FDA Drug Approval Details