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Generated: September 24, 2018

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Details for New Drug Application (NDA): 071333

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Summary for 071333
Tradename:IBUPROFEN
Applicant:Amneal Pharms Ny
Ingredient:ibuprofen
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 071333
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IBUPROFEN ibuprofen TABLET;ORAL 071333 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-3527 0615-3527-39 30 TABLET in 1 BLISTER PACK (0615-3527-39)
IBUPROFEN ibuprofen TABLET;ORAL 071333 ANDA Apotheca Inc. 12634-860 12634-860-01 100 TABLET in 1 BOTTLE, PLASTIC (12634-860-01)

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength200MG
Approval Date:Feb 17, 1987TE:RLD:No

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