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Details for New Drug Application (NDA): 074358

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NDA 074358 describes FLURBIPROFEN, which is a drug marketed by Teva, Ivax Sub Teva Pharms, Pliva, Aurolife Pharma Llc, Mylan, Sun Pharm Inds Inc, Theragen, and Bausch And Lomb, and is included in nine NDAs. It is available from eight suppliers. Additional details are available on the FLURBIPROFEN profile page.

The generic ingredient in FLURBIPROFEN is flurbiprofen sodium. There are eleven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the flurbiprofen sodium profile page.

Summary for NDA: 074358

Therapeutic Class:Analgesics
Anti-inflammatory Agents

Pharmacology for NDA: 074358

Suppliers and Packaging for NDA: 074358

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 074358 ANDA Mylan Pharmaceuticals Inc. 0378-0076 0378-0076-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0076-01)
TABLET;ORAL 074358 ANDA Mylan Pharmaceuticals Inc. 0378-0093 0378-0093-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0093-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Jun 20, 1994TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Jun 20, 1994TE:ABRLD:Yes

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