Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Sun Pharmaceutical Industries, Inc.
146974886
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Ohm Laboratories Inc.
Sun Pharmaceutical Industries, Inc.
Sun Pharmaceutical Industries, Inc.
184769029
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fosamprenavir Calcium
Product Details
NDC Product Code
63304-583Application Number
ANDA204024Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 2, 2019FosamprenavirActive
Code: ID1GU2627NClass: ACTIRQuantity: 700 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4BClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT