MedPath
FDA Approval

clobazam

February 28, 2023

HUMAN PRESCRIPTION DRUG LABEL

Clobazam(10 mg in 1 1)

Manufacturing Establishments (1)

Centaur Pharmaceuticals Private Limited

Breckenridge Pharmaceutical, Inc.

675596622

Products (3)

clobazam

51991-900

ANDA209308

ANDA (C73584)

ORAL

January 1, 2023

ClobazamActive
Code: 2MRO291B4UClass: ACTIBQuantity: 10 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT

clobazam

51991-958

ANDA209308

ANDA (C73584)

ORAL

January 1, 2023

ClobazamActive
Code: 2MRO291B4UClass: ACTIBQuantity: 5 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT

clobazam

51991-901

ANDA209308

ANDA (C73584)

ORAL

January 1, 2023

ClobazamActive
Code: 2MRO291B4UClass: ACTIBQuantity: 20 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
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