First-Time Generics - October 2007

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First-Time Generic Approvals - October 2007

Tablets/Capsules Only
Generic
Drug Name		 Generic
Manufacturer		 Referenced
Brand Name		 Approval
Date		 Pill
Identification
NIFEDIPINE EXTENDED-RELEASE TABLETS USP, 90 MG OSMOTICA PROCARDIA XL TABLETS 10-03-07
RISEDRONATE SODIUM TABLETS, 5 MG, 30 MG, AND 35 MG TEVA ACTONEL TABLETS 10-05-07 5 mg - round yellow 93 7390; 30 mg - round white 93 7392; 35 mg - round orange 93 7389
OXCARBAZEPINE TABLETS, 150 MG, 300 MG, AND 600 MG ROXANE TRILEPTAL TABLETS 10-09-07 See oxcarbazepine imprints for pill ID
OXCARBAZEPINE TABLETS, 150 MG, 300 MG, AND 600 MG GLENMARK TRILEPTAL TABLETS 10-09-07 See oxcarbazepine imprints for pill ID
OXCARBAZEPINE TABLETS, 150 MG, 300 MG, AND 600 MG SUN (Caraco) TRILEPTAL TABLETS 10-09-07 See oxcarbazepine imprints for pill ID
HYDROCODONE BITARTRATE AND IBUPROFEN TABLETS, 2.5 MG/200 MG (NEW STRENGTH) INTERPHARM VICOPROFEN TABLETS 10-05-07
RIVASTIGMINE TARTRATE CAPSULES, 1.5 MG (BASE), 3 MG (BASE), 4.5 MG (BASE), AND 6 MG (BASE) SUN EXELON CAPSULES 10-22-07
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS USP, 1 MG/0.02 MG, 1 MG/0.03 MG, 1 MG/0.035 MG (28-DAY) BARR ESTROSTEP FE TABLETS 10-26-07
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS USP, 1 MG/0.02 MG, 1 MG/0.03 MG, 1 MG/0.035 MG (21-DAY) BARR ESTROSTEP-21 TABLETS 10-26-07

Source: US Food and Drug Administration


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Submitted by TP Admin on November 25, 2007 - 5:24pm. login or register to post comments