Darunavir 600 and 800 mg

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Cipla USA Inc.

DUNS Number

078719707

Manufacturing Establishments3

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

CIPLA LIMITED KURKUMBH

Labeler

Cipla USA Inc.

Registrant

Cipla USA Inc.

DUNS Number

917066446

InvaGen Pharmaceuticals, Inc

Labeler

Cipla USA Inc.

Registrant

Cipla USA Inc.

DUNS Number

080334903

CIPLA LIMITED PATALGANGA

Labeler

Cipla USA Inc.

Registrant

Cipla USA Inc.

DUNS Number

916940208

Products2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Product Details

NDC Product Code

69097-244

Application Number

ANDA206288

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 10, 2023

Ingredients

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYETHYLENE GLYCOL 3350Inactive

Code: G2M7P15E5PClass: IACT

CROSPOVIDONE (15 MPA.S AT 5%)Inactive

Code: 68401960MKClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

DarunavirActive

Code: KPC4NRB25LClass: ACTIMQuantity: 800 mg in 1 1