MedPath
FDA Approval

Darunavir

Dr.Reddys Laboratories Inc (DUNS: 802315887)

November 25, 2023

HUMAN PRESCRIPTION DRUG LABEL

Darunavir(600 mg in 1 1)

Manufacturing Establishments (1)

Laurus Laboratories Limited

Dr.Reddys Laboratories Inc

650885309

Products (2)

Darunavir

43598-704

ANDA211578

ANDA (C73584)

ORAL

November 25, 2023

DarunavirActive
Code: YO603Y8113Class: ACTIBQuantity: 600 mg in 1 1
Silicon DioxideInactive
Code: ETJ7Z6XBU4Class: IACT
Magnesium StearateInactive
Code: 70097M6I30Class: IACT
Croscarmellose SodiumInactive
Code: M28OL1HH48Class: IACT
Microcrystalline CelluloseInactive
Code: OP1R32D61UClass: IACT
Polyvinyl Alcohol, UnspecifiedInactive
Code: 532B59J990Class: IACT
Polyethylene Glycol 3350Inactive
Code: G2M7P15E5PClass: IACT
TalcInactive
Code: 7SEV7J4R1UClass: IACT
Titanium DioxideInactive
Code: 15FIX9V2JPClass: IACT

Darunavir

43598-705

ANDA211578

ANDA (C73584)

ORAL

November 25, 2023

Silicon DioxideInactive
Code: ETJ7Z6XBU4Class: IACT
Magnesium StearateInactive
Code: 70097M6I30Class: IACT
Microcrystalline CelluloseInactive
Code: OP1R32D61UClass: IACT
DarunavirActive
Code: YO603Y8113Class: ACTIBQuantity: 800 mg in 1 1
Croscarmellose SodiumInactive
Code: M28OL1HH48Class: IACT
Polyethylene Glycol 3350Inactive
Code: G2M7P15E5PClass: IACT
Polyvinyl Alcohol, UnspecifiedInactive
Code: 532B59J990Class: IACT
TalcInactive
Code: 7SEV7J4R1UClass: IACT
Titanium DioxideInactive
Code: 15FIX9V2JPClass: IACT
Fd&C Blue No. 1Inactive
Code: H3R47K3TBDClass: IACT
Fd&C Blue No. 2Inactive
Code: L06K8R7DQKClass: IACT
Fd&C Red No. 40Inactive
Code: WZB9127XOAClass: IACT
Aluminum OxideInactive
Code: LMI26O6933Class: IACT
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