Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Qingdao BAHEAL Pharmaceutical Co.,Ltd.
Qingdao BAHEAL Pharmaceutical Co., Ltd.
Qingdao BAHEAL Pharmaceutical Co.,Ltd.
546626586
Products4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
CELECOXIB
Product Details
NDC Product Code
70247-006Application Number
ANDA208856Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 8, 2024LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
D&C RED NO. 7Inactive
Code: ECW0LZ41X8Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3Class: IACT
CelecoxibActive
Code: JCX84Q7J1LClass: ACTIBQuantity: 50 mg in 1 1
CELECOXIB
Product Details
NDC Product Code
70247-007Application Number
ANDA208856Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 8, 2024AMMONIAInactive
Code: 5138Q19F1XClass: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3Class: IACT
CelecoxibActive
Code: JCX84Q7J1LClass: ACTIBQuantity: 100 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
CELECOXIB
Product Details
NDC Product Code
70247-008Application Number
ANDA208856Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 8, 2024FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1OClass: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
CelecoxibActive
Code: JCX84Q7J1LClass: ACTIBQuantity: 200 mg in 1 1
CELECOXIB
Product Details
NDC Product Code
70247-009Application Number
ANDA208856Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 8, 2024CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3Class: IACT
CelecoxibActive
Code: JCX84Q7J1LClass: ACTIBQuantity: 400 mg in 1 1
AMMONIAInactive
Code: 5138Q19F1XClass: IACT