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Generated: September 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018858

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NDA 018858 describes INDOMETHACIN, which is a drug marketed by Sun Pharm Inds, Glenmark Pharms Ltd, Sun Pharm Inds Inc, Zydus Pharms Usa Inc, Jubilant Generics, Parke Davis, Hetero Labs Ltd Iii, Inwood Labs, Cycle Pharms Ltd, Pioneer Pharms, Able, G And W Labs, Ivax Sub Teva Pharms, Mylan, Duramed Pharms Barr, Chartwell Rx, Chartwell Molecules, Watson Labs, Halsey, Fresenius Kabi Usa, Mylan Pharms Inc, Teva, Aurobindo Pharma Ltd, Pliva, Amneal Pharms, Heritage Pharms Inc, Novast Labs Ltd, Sandoz, Mutual Pharm, Watson Labs Inc, Avanthi Inc, Glenmark Generics, Superpharm, West-ward Pharms Int, Hospira Inc, and Navinta Llc, and is included in sixty-one 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. One supplier is listed for this compound. Additional details are available on the indomethacin sodium profile page.

Summary for NDA: 018858

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

Pharmacology for NDA: 018858

Suppliers and Packaging for NDA: 018858

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INDOMETHACIN
indomethacin
CAPSULE;ORAL 018858 NDA Mylan Pharmaceuticals Inc. 0378-0143 0378-0143-01 100 CAPSULE in 1 BOTTLE, UNIT-DOSE (0378-0143-01)
INDOMETHACIN
indomethacin
CAPSULE;ORAL 018858 NDA Mylan Pharmaceuticals Inc. 0378-0143 0378-0143-10 1000 CAPSULE in 1 BOTTLE, UNIT-DOSE (0378-0143-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength25MG
Approval Date:Apr 20, 1984TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength50MG
Approval Date:Apr 20, 1984TE:RLD:No


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