MedPath
FDA Approval

Zolmitriptan

January 30, 2023

Human Prescription Drug Label

Zolmitriptan(5 mg in 1 1)

Manufacturing Establishments (1)

Alembic Pharmaceuticals Limited

Alembic Pharmaceuticals Limited

650574671

Products (2)

Zolmitriptan

46708-463

ANDA204232

ANDA (C73584)

ORAL

January 30, 2023

MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
Code: 2FS66TH3YWClass: ACTIBQuantity: 5 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WEClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT

Zolmitriptan

46708-462

ANDA204232

ANDA (C73584)

ORAL

January 30, 2023

MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
Code: 2FS66TH3YWClass: ACTIBQuantity: 2.5 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
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