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Details for New Drug Application (NDA): 073262

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NDA 073262 describes SULINDAC, which is a drug marketed by Epic Pharma, Sandoz, Mylan, Sun Pharm Inds, Heritage Pharms Inc, Ani Pharms Inc, and Watson Labs, and is included in twelve NDAs. It is available from twenty-one suppliers. Additional details are available on the SULINDAC profile page.

The generic ingredient in SULINDAC is sulindac. There are fourteen drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the sulindac profile page.

Summary for NDA: 073262

Tradename:
SULINDAC
Applicant:
Heritage Pharms Inc
Ingredient:
sulindac
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 073262

Suppliers and Packaging for NDA: 073262

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SULINDAC
sulindac
TABLET;ORAL 073262 ANDA Heritage Pharmaceuticals Inc. 23155-005 23155-005-01 100 TABLET in 1 BOTTLE (23155-005-01)
SULINDAC
sulindac
TABLET;ORAL 073262 ANDA Heritage Pharmaceuticals Inc. 23155-005 23155-005-05 500 TABLET in 1 BOTTLE (23155-005-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Sep 6, 1991TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Sep 6, 1991TE:ABRLD: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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