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FDA approval activities for this prescription drug:

IBU (Ibuprofen) Tablets, 400, 600 & 800 mg, BASF ANDA 75-682 11/14/01 4/14/03 Ibuprofen Capsules, 200 mg Banner Pharmacaps, NDA 21-472 10/18/02 10/28/02 Ibuprofen Capsules, 200 mg, OTC Pharmaceutical Formulations ANDA 74-782 7/6/98 7/6/98 3/30/99 Ibuprofen Suspension USP, 100 mg/5 mL, OTC Alpharma ANDA 74-916 1/9/98 3/15/99 Ibuprofen Suspension USP, 100 mg/5 mL. L. Perrigo Company ANDA 74-937 12/22/98 12/22/98 1/10/02 1/10/02 Ibuprofen Suspension USP, 100 mg/5 mL, Alpharma ANDA 74-978 1/30/98 3/25/98 3/19/99 Ibuprofen Suspension USP, 40 mg/mL. L. Perrigo Company ANDA 75-217 12/16/98 12/18/98 12/28/01 12/28/01 Ibuprofen and Pseudoephedrine Hydrochloride Tablets USP, 200 mg & 30 mg, OTC Pharmaceutical Formulations, ANDA 75-588 4/8/02 4/10/03 Ibuprofen and Pseudoephedrine Hydrochloride Tablets USP, 200 mg & 30 mg, OTC Tentatively Approved Pharmaceutical Formulations, ANDA 75-588 4/17/01 4/24/01 Ibuprofen and Pseudoephedrine Hydrochloride Tablets USP, 200 mg/30 mg, OTC Ohm , ANDA 74-567 4/17/01 4/24/01 Ibuprofen Tablets (round and capsule shaped tablets) USP, 200mg Novopharm N.C. ANDA 74-931 7/20/98 7/20/98 Ibuprofen Tablets (round and capsule shaped tablets) USP, 200mg LNK International ANDA 75-139 3/1/99 3/4/99 Ibuprofen Tablets USP, 200 mg, OTC Dr. Reddy's Ltd. ANDA 76-117 11/20/01 4/16/03 Ibuprofen Tablets USP, 400, 600 & 800 mg, Dr. Reddy's Ltd. ANDA 76-112 10/31/01 1/17/02 1/17/02 Ibuprofen Tablets USP, 200mg, OTC L. Perrigo Company ANDA 75-995 3/14/02 4/10/03 Ibuprofen Tablets USP, 200mg, OTC BASF Corp. ANDA 75-661 12/12/01 Ibuprofen Tablets USP, 200mg LNK International ANDA 75-010 Infant's Motrin (ibuprofen oral suspension) Concentrated Drops, 50 mg/1.25 mL McNeil Consumer Healthcare NDA 20-603/S-003 4/15/99 4/30/02 Infant's Motrin (50 mg/1.25 mL ibuprofen oral suspension). McNeil Consumer & Specialty NDA 20-603/S-005 1/16/02 2/7/02 2/7/02 Infants' Advil (ibuprofen oral suspension) Concentrated Drops,50 mg/1.25 mL. Whitehall-Robins Healthcare NDA 21-812/SE5-003 1/12/00 1/21/00 1/21/00 Infants' Advil Indications: For use in children 6 months - 23 months Motrin Sinus/Headache (Ibuprofen & Pseudoephedrine HCI) Caplets, McNeil Consumer and Specialty NDA 19-899/S15 7/29/03 8/6/03 8/6/03 Motrin Sinus/Headache (Ibuprofen & Pseudoephedrine HCI) Caplets, McNeil Consumer and Specialty NDA 19-899/S8, S11 & S12 9/3/02 9/11/02 Motrin Suspension, Chewable Tablets, Caplets & Drops, McNeil Consumer Healthcare NDA 19482/S-013, 20135/S-005, 20418/S-003 & 20476/S-002 2/4/02 4/17/02 Motrin IB & Children's Motrin (Ibuprofen) Caplets & Suspention, McNeil Consumer NDA 19-012/S34 & 20-516/S11 10/28/03 Motrin Migraine Pain, Tablets Caplets & Geltabs, McNeil Consumer Healthcare NDA 19-012/S016 2/25/00 3/2/00 5/14/02 5/14/02 Motrin Indications: Treats pain of migraine headache. Ibuprofen and Pseudoephedrine Hydrochloride Suspension, Perrigo Co. Motrin IB & Children's Motrin (Ibuprofen) Caplets & Suspention, McNeil Consumer HYDROCODONE BITARTRATE; IBUPROFEN Tablet; 7.5MG;200MG VICOPROFEN ABBOTT 076023 HYDROCODONE BITARTRATE; IBUPROFEN Tablet; 7.5MG;200MG HYDROCODONE BITARTRATE AND IBUPROFEN TEVA 074978 IBUPROFEN Suspension; 100MG/5ML IBUPROFEN ALPHARMA 019842 IBUPROFEN Suspension; 100MG/5ML MOTRIN MCNEIL CONS SPECLT 019833 BX IBUPROFEN Suspension; 100MG/5ML CHILDREN'S ADVIL WYETH CONS 071058 IBUPROFEN Tablet; 400MG IBU-TAB ALRA 071059 IBUPROFEN Tablet; 600MG IBU-TAB ALRA 018197 IBUPROFEN Tablet; 400MG IBU BASF 070083 IBUPROFEN Tablet; 400MG IBU BASF 075682 IBUPROFEN Tablet; 400MG IBUPROFEN BASF 075682 IBUPROFEN Tablet; 600MG IBUPROFEN BASF 070088 IBUPROFEN Tablet; 600MG IBU BASF 070099 IBUPROFEN Tablet; 600MG IBU BASF 070745 IBUPROFEN Tablet; 800MG IBU BASF 075682 IBUPROFEN Tablet; 800MG IBUPROFEN BASF 076112 IBUPROFEN Tablet; 400MG IBUPROFEN DR REDDYS INC 076112 IBUPROFEN Tablet; 600MG IBUPROFEN DR REDDYS INC 076112 IBUPROFEN Tablet; 800MG IBUPROFEN DR REDDYS INC 070734 IBUPROFEN Tablet; 300MG IBUPROFEN GENEVA 070735 IBUPROFEN Tablet; 400MG IBUPROFEN GENEVA 070736 IBUPROFEN Tablet; 600MG IBUPROFEN GENEVA 072169 IBUPROFEN Tablet; 800MG IBUPROFEN GENEVA 071334 IBUPROFEN Tablet; 400MG IBUPROFEN INTERPHARM 071335 IBUPROFEN Tablet; 600MG IBUPROFEN INTERPHARM 071935 IBUPROFEN Tablet; 800MG IBUPROFEN INTERPHARM 071145 IBUPROFEN Tablet; 400MG IBUPROFEN IVAX 071146 IBUPROFEN Tablet; 600MG IBUPROFEN IVAX 071769 IBUPROFEN Tablet; 800MG IBUPROFEN IVAX 017463 IBUPROFEN Tablet; 300MG MOTRIN MCNEIL CONS SPECLT 017463 IBUPROFEN Tablet; 400MG MOTRIN MCNEIL CONS SPECLT 017463 IBUPROFEN Tablet; 600MG MOTRIN MCNEIL CONS SPECLT 017463 IBUPROFEN Tablet; 800MG MOTRIN MCNEIL CONS SPECLT 071230 IBUPROFEN Tablet; 300MG IBUPROFEN MUTUAL 071231 IBUPROFEN Tablet; 400MG IBUPROFEN MUTUAL 071232 IBUPROFEN Tablet; 600MG IBUPROFEN MUTUAL 072004 IBUPROFEN Tablet; 800MG IBUPROFEN MUTUAL 070045 IBUPROFEN Tablet; 400MG IBUPROFEN MYLAN 070057 IBUPROFEN Tablet; 600MG IBUPROFEN MYLAN 071999 IBUPROFEN Tablet; 800MG IBUPROFEN MYLAN 070818 IBUPROFEN Tablet; 400MG IBUPROFEN OHM 070469 IBUPROFEN Tablet; 400MG IBUPROHM OHM 070329 IBUPROFEN Tablet; 400MG IBUPROFEN PAR 070330 IBUPROFEN Tablet; 600MG IBUPROFEN PAR 070986 IBUPROFEN Tablet; 800MG IBUPROFEN PAR 071666 IBUPROFEN Tablet; 400MG IBUPROFEN PLIVA 071667 IBUPROFEN Tablet; 600MG IBUPROFEN PLIVA 071668 IBUPROFEN Tablet; 800MG IBUPROFEN PLIVA 071266 IBUPROFEN Tablet; 300MG IBUPROFEN PVT FORM 071267 IBUPROFEN Tablet; 400MG IBUPROFEN PVT FORM 071268 IBUPROFEN Tablet; 600MG IBUPROFEN PVT FORM 072300 IBUPROFEN Tablet; 800MG IBUPROFEN PVT FORM 071644 IBUPROFEN Tablet; 400MG IBUPROFEN VINTAGE 070436 IBUPROFEN Tablet; 400MG IBUPROFEN WATSON 070437 IBUPROFEN Tablet; 600MG IBUPROFEN WATSON 071547 IBUPROFEN Tablet; 800MG IBUPROFEN WATSON Ibuprofen Tablets, Neil Children's Motrin (Ibuprofen) Suspension Children's Motrin Cold (Pseudoephedrine HCI) Suspension, McNeil Consumer

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