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Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 070673

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NDA 070673 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-four 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 070673

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 070673

Suppliers and Packaging for NDA: 070673

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INDOMETHACIN indomethacin CAPSULE;ORAL 070673 ANDA Sandoz Inc 0781-2325 0781-2325-01 100 CAPSULE in 1 BOTTLE (0781-2325-01)
INDOMETHACIN indomethacin CAPSULE;ORAL 070673 ANDA Sandoz Inc 0781-2325 0781-2325-10 1000 CAPSULE in 1 BOTTLE (0781-2325-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength25MG
Approval Date:Apr 29, 1987TE:ABRLD:No


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