Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
TIME CAP LABORATORIES, INC
037052099
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
MARKSANS PHARMA LIMITED
TIME CAP LABORATORIES, INC
TIME CAP LABORATORIES, INC
925822975
Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
IBUPROFEN
Product Details
NDC Product Code
49483-602Application Number
ANDA090796Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 30, 2019SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990Class: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
IbuprofenActive
Code: WK2XYI10QMClass: ACTIBQuantity: 400 mg in 1 1
IBUPROFEN
Product Details
NDC Product Code
49483-603Application Number
ANDA090796Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 30, 2019SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990Class: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
IbuprofenActive
Code: WK2XYI10QMClass: ACTIBQuantity: 600 mg in 1 1
IBUPROFEN
Product Details
NDC Product Code
49483-604Application Number
ANDA090796Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 30, 2019CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990Class: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
IbuprofenActive
Code: WK2XYI10QMClass: ACTIBQuantity: 800 mg in 1 1