Viewing data from:

ETODOLAC

ANDA

ETODOLAC | A075665 | TEVA PHARMACEUTICALS USA INC

3 strengths0 unique patents0 unique exclusivities

API Supply Chain11 active DMFs11 inactive

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

AMSA SPAETODOLAC

DMF 113591995

ZAKLADY FARMACEUTYCZNE POLPHARMA SAETODOLAC

DMF 114051995

TAPI NL BVETODOLAC

DMF 117661995

TARO PHARMACEUTICAL INDUSTRIES LTDETODOLAC USP MICRONIZED

DMF 153392001

ZHEJIANG CHIRAL MEDICINE CHEMICALS CO LTDETODOLAC

DMF 167892003

ZYDUS LIFESCIENCES LTDETODOLAC USP

DMF 236882010

KREATIVE ORGANICS PRIVATE LTDETODOLAC USP

DMF 244222010

IPCA LABORATORIES LTDETODOLAC USP (ED6 PROCESS)

DMF 248682011

ULKAR KIMYA SANAYII VE TICARET ASETODOLAC

DMF 249362011

EMCURE PHARMACEUTICALS LTDETODOLAC USP

DMF 258082012

IPCA LABORATORIES LTDETODOLAC USP (ED7 PROCESS)

DMF 275122013

LEDERLE LABORATORIES DIV AMERICAN CYANAMID COInactiveETODOLAC (ETODOLIC ACID)

DMF 53461984

UPJOHN COInactiveETODOLAC MICRONIZED AS PROCESSED IN THE KALAMAZOO, MICHIGAN FACILITY

DMF 53831984

LONZA INCInactiveETODOLAC INTERMEDIATES

DMF 54371984

LONZA AGInactiveETODOLAC

DMF 57951985

QUIMICA SINTETICA SAInactiveETODOLAC

DMF 95291992

CHEMI SPAInactiveETODOLAC

DMF 117401995

RANBAXY PHARMACEUTICALS INCInactiveETODOLAC DRUG SUBSTANCE

DMF 126181997

CHEMSOURCE CORPInactiveETODOLAC DRUG SUBSTANCE

DMF 142981999

IPCA LABORATORIES LTDInactiveETODOLAC

DMF 214492008

YANGZHOU PHARMACEUTICAL CO LTDInactiveETODOLAC USP

DMF 215782008

FLEMING LABORATORIES LTDInactiveETODOLAC USP

DMF 319672017

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Feb 5, 2001	SUPPL -3	View Letter (PDF)
Feb 5, 2001	SUPPL -1	View Letter (PDF)
Feb 5, 2001	SUPPL -2	View Letter (PDF)
Jul 31, 2000	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 600MG

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Jul 31, 2000

No patent or exclusivity listings for this strength.

#002 — 500MG

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Jul 31, 2000

#003 — 400MG

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Feb 5, 2001