Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Blenheim Pharmacal, Inc.
171434587
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Blenheim Pharmacal, Inc.
Blenheim Pharmacal, Inc.
Blenheim Pharmacal, Inc.
171434587
Products1
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
10544-953Application Number
ANDA204197Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
April 21, 2016CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3Class: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
CelecoxibActive
Code: JCX84Q7J1LClass: ACTIBQuantity: 200 mg in 1 1
DIMETHICONEInactive
Code: 92RU3N3Y1OClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT