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Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 073314

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NDA 073314 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 073314

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

Pharmacology for NDA: 073314

Suppliers and Packaging for NDA: 073314

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INDOMETHACIN indomethacin SUPPOSITORY;RECTAL 073314 ANDA G & W LABORATORIES, INC. 0713-0176 0713-0176-30 30 SUPPOSITORY in 1 BOX (0713-0176-30)
INDOMETHACIN indomethacin SUPPOSITORY;RECTAL 073314 ANDA Iroko Pharmaceuticals, LLC 42211-102 42211-102-43 30 SUPPOSITORY in 1 BOX (42211-102-43)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUPPOSITORY;RECTALStrength50MG
Approval Date:Aug 31, 1992TE:RLD:No


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Serving leading biopharmaceutical companies globally:

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