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FDA Approval

CELECOXIB

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

FDA Approval Summary

Company
RedPharm Drug, Inc.
DUNS: 828374897
Effective Date
January 21, 2022
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.

RedPharm Drug, Inc.

RedPharm Drug, Inc.

828374897

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
67296-1345
Application Number
ANDA207446
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
January 21, 2022
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CelecoxibActive
Code: JCX84Q7J1LClass: ACTIBQuantity: 200 mg in 1 1
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