MedPath
FDA Approval

Celecoxib

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
September 18, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Celecoxib(200 mg in 1 1)

Manufacturing Establishments1

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

NuCare Pharmaceuticals,Inc.

NuCare Pharmaceuticals,Inc.

010632300

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
68071-2733
Application Number
ANDA205129
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
September 18, 2023
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
CelecoxibActive
Code: JCX84Q7J1LClass: ACTIBQuantity: 200 mg in 1 1
© Copyright 2025. All Rights Reserved by MedPath