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Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078857

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NDA 078857 describes CELECOXIB, which is a drug marketed by Alembic Pharms Ltd, Apotex Inc, Aurobindo Pharma Ltd, Cipla Ltd, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Teva, Torrent Pharms Ltd, and Watson Labs Inc, and is included in eleven NDAs. It is available from forty suppliers. Additional details are available on the CELECOXIB profile page.

The generic ingredient in CELECOXIB is celecoxib. There are twenty-six drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the celecoxib profile page.
Summary for 078857
Tradename:CELECOXIB
Applicant:Mylan Pharms Inc
Ingredient:celecoxib
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 078857
Medical Subject Heading (MeSH) Categories for 078857
Suppliers and Packaging for NDA: 078857
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CELECOXIB celecoxib CAPSULE;ORAL 078857 ANDA Mylan Pharmaceuticals Inc. 0378-7150 0378-7150-05 500 CAPSULE in 1 BOTTLE, PLASTIC (0378-7150-05)
CELECOXIB celecoxib CAPSULE;ORAL 078857 ANDA Mylan Pharmaceuticals Inc. 0378-7150 0378-7150-01 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-7150-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:May 30, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Feb 11, 2015TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Feb 11, 2015TE:ABRLD:No

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