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Serving leading biopharmaceutical companies globally:

Fish and Richardson
US Army

Generated: February 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090619

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NDA 090619 describes IBUPROFEN AND DIPHENHYDRAMINE CITRATE, which is a drug marketed by Dr Reddys Labs Ltd and Perrigo R And D and is included in two NDAs. It is available from thirty-one suppliers. Additional details are available on the IBUPROFEN AND DIPHENHYDRAMINE CITRATE profile page.

The generic ingredient in IBUPROFEN AND DIPHENHYDRAMINE CITRATE is diphenhydramine citrate; ibuprofen. There are twenty-three drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the diphenhydramine citrate; ibuprofen profile page.
Summary for 090619
Applicant:Dr Reddys Labs Ltd
Ingredient:diphenhydramine citrate; ibuprofen
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 090619
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IBUPROFEN AND DIPHENHYDRAMINE CITRATE diphenhydramine citrate; ibuprofen TABLET;ORAL 090619 ANDA Dr. Reddy's Laboratories Limited 55111-565 N 55111-565-30
IBUPROFEN AND DIPHENHYDRAMINE CITRATE diphenhydramine citrate; ibuprofen TABLET;ORAL 090619 ANDA Dr. Reddy's Laboratories Limited 55111-565 N 55111-565-18

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength38MG;200MG
Approval Date:Jul 8, 2009TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
US Army
Queensland Health
Farmers Insurance

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