Viewing data from:

OXAPROZIN

ANDA

OXAPROZIN | A075845 | PANGEA PHARMACEUTICALS LLC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: DAYPRO(TE code: AB)

API Supply Chain4 active DMFs9 inactive

4 active API suppliers hold Drug Master Files for this ingredient.

KATWIJK CHEMIE BVOXAPROZIN

DMF 113081995

OLON SPAOXAPROZIN

DMF 129111998

COSMA SPAOXAPROZIN

DMF 129991998

DR REDDYS LABORATORIES LTDOXAPROZIN USP

DMF 144281999

DSM PHARMA CHEMICALS SOUTH HAVEN INCInactiveOXAPROZIN

DMF 111561994

SUMITOMO CHEMICAL CO LTDInactiveOXAPROZIN

DMF 117481995

MEDICHEM SAInactiveOXAPROZIN

DMF 118621996

CILAG AGInactiveOXAPROZIN

DMF 118671996

CORDEN PHARMA BERGAMO SPAInactiveOXAPROZIN

DMF 123401997

CHINA CHEMICAL SYNTHESIS INDUSTRIAL CO LTDInactiveOXAPROZIN (BULK ACTIVE PHARMACEUTICAL INGREDIENT)

DMF 131191998

ZAMBON GROUP SPAInactiveOXAPROZIN

DMF 132271998

ERREGIERRE SPAInactiveOXAPROZIN JP

DMF 140591999

SOCIETA ITALIANA MEDICINALI SCANDICCIInactiveOXAPROZIN

DMF 154842001

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jan 31, 2001	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 600MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jan 31, 2001

No patent or exclusivity listings for this strength.