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Details for New Drug Application (NDA): 070813

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NDA 070813 describes INDOMETHACIN, which is a drug marketed by Sun Pharm Inds, 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, Paddock Llc, Vintage, Watson Labs, Halsey, Fresenius Kabi Usa, Mylan Pharms Inc, Teva, Pliva, Amneal Pharms, Heritage Pharms Inc, Sandoz, Mutual Pharm, Watson Labs Inc, Avanthi Inc, Glenmark Generics, Superpharm, Eurohlth Intl Sarl, and Hospira Inc, and is included in fifty-six 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. Additional details are available on the indomethacin sodium profile page.

Summary for NDA: 070813

Pioneer Pharms
Therapeutic Class:Analgesics
Anti-inflammatory Agents

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength25MG
Approval Date:Aug 11, 1986TE: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.