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Generated: September 20, 2018

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Details for New Drug Application (NDA): 072199

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Summary for 072199
Tradename:IBUPROFEN
Applicant:Amneal Pharms Ny
Ingredient:ibuprofen
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 072199
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IBUPROFEN ibuprofen TABLET;ORAL 072199 ANDA The Kroger Co. 30142-167 30142-167-05 500 TABLET in 1 BOTTLE (30142-167-05)
IBUPROFEN ibuprofen TABLET;ORAL 072199 ANDA Amneal Pharmaceuticals 53746-142 53746-142-01 100 TABLET in 1 BOTTLE (53746-142-01)

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength200MG
Approval Date:May 23, 1988TE:RLD:No

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