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Report / Drug application metadata

CELECOXIB

The application ANDA213301 lists 4 product formulations. Its sponsor is UNICHEM. The product details below come from the application record, not a prescribing guide.

Which products are in this application?

CELECOXIB

Active ingredients
CELECOXIB 400MG
Dosage form
CAPSULE
Route
ORAL
Marketing status
Discontinued
Product number
004

CELECOXIB

Active ingredients
CELECOXIB 100MG
Dosage form
CAPSULE
Route
ORAL
Marketing status
Discontinued
Product number
002

CELECOXIB

Active ingredients
CELECOXIB 200MG
Dosage form
CAPSULE
Route
ORAL
Marketing status
Discontinued
Product number
003

CELECOXIB

Active ingredients
CELECOXIB 50MG
Dosage form
CAPSULE
Route
ORAL
Marketing status
Discontinued
Product number
001

How should this information be used?

An application can contain several product versions and a history of submissions. The details shown here do not establish current availability in a particular country or pharmacy, and a listed strength is not a recommended dose. Check the current approved product label for indications, contraindications, warnings and dosing.

This page does not infer a medicine's treatment uses from its name or regulatory status. Application metadata is evidence about the listed product, not evidence that it is suitable for an individual patient.

Kind
Drug application metadata
Identifier
ANDA213301
Sponsor
UNICHEM

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