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Generated: August 22, 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 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, and Hospira Inc, and is included in fifty-nine NDAs. It is available from fifty-two 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: 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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