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Details for New Drug Application (NDA): 040274

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NDA 040274 describes HYDROXYCHLOROQUINE SULFATE, which is a drug marketed by Sandoz, Watson Labs, Zydus Pharms Usa Inc, Hikma Pharms Llc, Ipca Labs Ltd, Mylan, and Teva Pharms, and is included in eight NDAs. It is available from twenty-six suppliers. Additional details are available on the HYDROXYCHLOROQUINE SULFATE profile page.

The generic ingredient in HYDROXYCHLOROQUINE SULFATE is hydroxychloroquine sulfate. There are fourteen drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the hydroxychloroquine sulfate profile page.

Summary for NDA: 040274

hydroxychloroquine sulfate
Therapeutic Class:Antiparasitics

Pharmacology for NDA: 040274

Suppliers and Packaging for NDA: 040274

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
hydroxychloroquine sulfate
TABLET;ORAL 040274 ANDA Mylan Pharmaceuticals Inc. 0378-0373 0378-0373-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0373-01)
hydroxychloroquine sulfate
TABLET;ORAL 040274 ANDA Mylan Institutional Inc. 42292-011 42292-011-06 50 BLISTER PACK in 1 BOX, UNIT-DOSE (42292-011-06) > 1 TABLET, FILM COATED in 1 BLISTER PACK (42292-011-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:May 29, 1998TE:ABRLD:No

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