First-Time Generics - December 2007

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Joined: 2005-01-07

First-Time Generic Approvals - December 2007

Tablets/Capsules Only
Generic
Drug Name
Generic
Manufacturer
Referenced
Brand Name
Approval
Date
Pill
Identification
EXTENDED PHENYTOIN SODIUM CAPSULES, USP 30 MG WOCKHARDT DILANTIN (EXTENDED PHENYTOIN SODIUM CAPSULES) 12-18-07
CETIRIZINE HYDROCHLORIDE TABLETS, (OTC), 5 MG AND 10

MG

MYLAN ZYRTEC ALLERGY/ZYRTEC HIVES RELIEF TABLETS 12-27-07 5 mg - round white M C35; 10 mg - round white M C37
CETIRIZINE HYDROCHLORIDE TABLETS, (OTC), 5 MG AND 10

MG

CARACO ZYRTEC ALLERGY/ZYRTEC HIVES RELIEF TABLETS 12-27-07
CETIRIZINE HYDROCHLORIDE TABLETS, (OTC), 5 MG AND 10

MG

PAR ZYRTEC ALLERGY/ZYRTEC HIVES RELIEF TABLETS 12-27-07
CETIRIZINE HYDROCHLORIDE TABLETS, (OTC), 5 MG AND 10

MG

RANBAXY ZYRTEC ALLERGY/ZYRTEC HIVES RELIEF TABLETS 12-27-07
CETIRIZINE HYDROCHLORIDE TABLETS, (OTC), 5 MG AND 10

MG

SANDOZ ZYRTEC ALLERGY/ZYRTEC HIVES RELIEF TABLETS 12-27-07 5 mg - round white SZ 905; 10 mg - round white SZ 906
CETIRIZINE HYDROCHLORIDE TABLETS, (OTC), 5 MG AND 10

MG

APOTEX ZYRTEC ALLERGY/ZYRTEC HIVES RELIEF TABLETS 12-27-07 5 mg - pillow shaped white APO 5 mg; 10 mg - pillow shaped white

APO 10 mg

CETIRIZINE HYDROCHLORIDE TABLETS, (OTC), 5 MG AND 10

MG

ACTAVIS ZYRTEC ALLERGY/ZYRTEC HIVES RELIEF TABLETS 12-27-07
CETIRIZINE HYDROCHLORIDE TABLETS, (OTC), 5 MG AND 10

MG

WOCKHARDT ZYRTEC ALLERGY/ZYRTEC HIVES RELIEF TABLETS 12-27-07
CETIRIZINE HYDROCHLORIDE TABLETS, (OTC), 5 MG AND 10

MG

PERRIGO ZYRTEC ALLERGY/ZYRTEC HIVES RELIEF TABLETS 12-27-07 10 mg - oval white 4H2
BALSALAZIDE DISODIUM CAPSULES 750 MG ROXANE COLAZAL CAPSULES 12-28-07 Orange and opaque 54 795
GRANISETRON HYDROCHLORIDE TABLETS, 1 MG (BASE) BARR KYTRIL TABLETS 12-31-07
GRANISETRON HYDROCHLORIDE TABLETS, 1 MG (BASE) TEVA KYTRIL TABLETS 12-31-07 Oblong white 93 7485
GRANISETRON HYDROCHLORIDE TABLETS, 1 MG (BASE) COREPHARMA KYTRIL TABLETS 12-31-07
GRANISETRON HYDROCHLORIDE TABLETS, 1 MG (BASE) ROXANE KYTRIL TABLETS 12-31-07 Round white 54 922

Sources: US Food and Drug Administration and Manufacturers' Websites

Pill imprints updated 01-23-08