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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Boehringer Ingelheim
Express Scripts
US Department of Justice

Generated: June 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091549

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NDA 091549 describes INDOMETHACIN, which is a drug marketed by Able, Amneal Pharms, Aurobindo Pharma Ltd, Avanthi Inc, Chartwell Rx, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Inwood Labs, Jubilant Generics, Mylan Pharms Inc, Novast Labs Ltd, Sandoz, Watson Labs Inc, Zydus Pharms Usa Inc, Chartwell Molecules, Cycle Pharms Ltd, Duramed Pharms Barr, Glenmark Generics, Halsey, Heritage Pharms Inc, Ivax Sub Teva Pharms, Mutual Pharm, Mylan, Parke Davis, Pioneer Pharms, Pliva, Sun Pharm Inds Inc, Sun Pharm Industries, Superpharm, Teva, Watson Labs, Fresenius Kabi Usa, G And W Labs, Hospira Inc, Navinta Llc, and West-ward Pharms Int, and is included in sixty-two NDAs. It is available from fifty-five suppliers. Additional details are available on the INDOMETHACIN profile page.

The generic ingredient in INDOMETHACIN is indomethacin sodium. There are fifteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the indomethacin sodium profile page.
Summary for 091549
Applicant:Amneal Pharms
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 091549
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INDOMETHACIN indomethacin CAPSULE, EXTENDED RELEASE;ORAL 091549 ANDA Blenheim Pharmacal, Inc. 10544-919 E 10544-919-14
INDOMETHACIN indomethacin CAPSULE, EXTENDED RELEASE;ORAL 091549 ANDA Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC 49999-371 N 49999-371-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength75MG
Approval Date:Dec 1, 2010TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Chinese Patent Office
Boehringer Ingelheim
US Department of Justice
Johnson and Johnson

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