MedPath
FDA Approval

Clobazam

February 17, 2021

Human Prescription Drug Label

Clobazam(20 mg in 1 1)

Registrants (1)

Piramal Healthcare UK Limited

345609965

Manufacturing Establishments (1)

Piramal Enterprises Limited

Sandoz Inc.

Piramal Healthcare UK Limited

862202793

Products (2)

Clobazam

0781-8014

ANDA209808

ANDA (C73584)

ORAL

February 22, 2021

LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
ClobazamActive
Code: 2MRO291B4UClass: ACTIBQuantity: 20 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT

Clobazam

0781-8013

ANDA209808

ANDA (C73584)

ORAL

February 22, 2021

LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
ClobazamActive
Code: 2MRO291B4UClass: ACTIBQuantity: 10 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
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