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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 203347


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NDA 203347 describes MARAVIROC, which is a drug marketed by Hetero Labs Ltd Iii and I 3 Pharms and is included in two NDAs. It is available from three suppliers. Additional details are available on the MARAVIROC profile page.

The generic ingredient in MARAVIROC is maraviroc. There are two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the maraviroc profile page.
Summary for 203347
Tradename:MARAVIROC
Applicant:Hetero Labs Ltd Iii
Ingredient:maraviroc
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203347
Suppliers and Packaging for NDA: 203347
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MARAVIROC maraviroc TABLET;ORAL 203347 ANDA Camber Pharmaceuticals, Inc. 31722-579 31722-579-60 60 TABLET, FILM COATED in 1 BOTTLE (31722-579-60)
MARAVIROC maraviroc TABLET;ORAL 203347 ANDA Camber Pharmaceuticals, Inc. 31722-580 31722-580-60 60 TABLET, FILM COATED in 1 BOTTLE (31722-580-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Feb 7, 2022TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Feb 7, 2022TE:ABRLD:No

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