| |
ANDA Number |
Generic Drug Name |
Applicant |
Tentative Approval Date |
| 1 |
77-416 |
RISPERIDONE ORAL SOLUTION 1 MG/ML |
RANBAXY LABORATORIES LIMITED |
8/3/2006 |
| 2 |
77-463 |
NATEGLINIDE TABLETS 60 MG AND 120 MG |
PAR PHARMACEUTICAL, INC. |
8/10/2006 |
| 3 |
78-195 |
NEVIRAPINE TABLETS 200 MG |
STRIDES ACROLAB LTD. |
8/11/2006 |
| 4 |
77-166 |
VENLAFAXINE HYDROCHLORIDE TABLETS 25 MG (BASE), 37.5 MG (BASE), 50 MG (BASE), 75 MG (BASE), AND 100 MG (BASE) |
MYLAN PHARMACEUTICALS INC. |
8/14/2006 |
| 5 |
77-732 |
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS 50 MG/12.5 MG AND 100 MG/25 MG |
ROXANE LABORATORIES, INC. |
8/16/2006 |
| 6 |
78-045 |
FLUOXETINE CAPSULES USP, 10 MG AND 20 MG (RLD=SARAFEM CAPSULES/LILLY) |
MYLAN PHARMACEUTICALS, INC. |
8/25/2006 |
| 7 |
77-753 |
CIPROFLOXACIN AND DEXTROSE (5%) INJECTION USP, 2 MG/ML; PACKAGED IN 200 MG/100 ML AND 400 MG/200 ML SINGLE-USE FLEXIBLE CONTAINERS |
HOSPIRA INC. |
8/28/2006 |
| 8 |
78-256 |
STAVUDINE CAPSULES USP, 30 MG AND 40 MG |
STRIDES ACROLAB LIMITED |
8/28/2006 |
| 9 |
77-713 |
SERTRALINE HYDROCHLORIDE TABLETS 25 MG (BASE), 50 MG (BASE), AND 100 MG (BASE) |
SANDOZ INC. |
8/29/2006 |
| 10 |
77-480 |
ONDANSETRON AND 5% DEXTROSE INJECTION 0.64 MG/ML, PACKAGED IN 32 MG/50 ML FLEXIBLE PLASTIC CONTAINERS |
SICOR PHARMACEUTICALS, INC. |
8/30/2006 |
| 11 |
77-763 |
CLOBETASOL PROPIONATE TOPICAL FOAM 0.05% |
PERRIGO ISRAEL PHARMACEUTICAL LTD. |
8/30/2006 |
| 12 |
77-773 |
ZOLPIDEM TARTRATE TABLETS 5 MG AND 10 MG |
WATSON LABORATORIES, INC. |
8/31/2006 |
