January 17, 2008 - 7:56pm
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 | 5 mg - oblong white 540; 10 mg - oblong white 541 |
| 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 | 5 mg - round white R 196; 10 mg - round white R 198 |
| 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 | Round white B 576 |
| 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 |
