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Details for New Drug Application (NDA): 204197

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NDA 204197 describes CELECOXIB, which is a drug marketed by Alembic Pharms Ltd, Aurobindo Pharma Ltd, Lupin Ltd, Cipla Ltd, Mylan Pharms Inc, Watson Labs Inc, Torrent Pharms Ltd, Macleods Pharms Ltd, Apotex Inc, and Teva, and is included in ten NDAs. It is available from thirty suppliers. Additional details are available on the CELECOXIB profile page.

The generic ingredient in CELECOXIB is celecoxib. There are twenty-three drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the celecoxib profile page.

Summary for NDA: 204197

Apotex Inc
Therapeutic Class:Analgesics
Anti-inflammatory Agents

Pharmacology for NDA: 204197

Suppliers and Packaging for NDA: 204197

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAPSULE;ORAL 204197 ANDA Major Pharmaceuticals 0904-6502 0904-6502-61 100 CAPSULE in 1 BOX, UNIT-DOSE (0904-6502-61)
CAPSULE;ORAL 204197 ANDA Major Pharmaceuticals 0904-6503 0904-6503-61 100 CAPSULE in 1 BOX, UNIT-DOSE (0904-6503-61)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:Jun 2, 2015TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Jun 2, 2015TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Jun 2, 2015TE:ABRLD:No

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