Drug Name and
FDA Appl. # |
Suppl. # |
Active Ingredients |
Company |
Approval Type |
Approval Date |
| AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE (ANDA # 078466) |
000 |
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE |
LUPIN LTD |
Approval |
02/05/2010 |
| BALANCED SALT SOLUTION (ANDA # 091387) |
000 |
CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE |
B BRAUN |
Approval |
02/03/2010 |
| CARISOPPRODOL, ASPIRIN AND CODEINE PHOSPHATE (ANDA # 040860) |
000 |
ASPIRIN; CARISOPRODOL; CODEINE PHOSPHATE |
CONCORD LABS NJ |
Approval |
01/07/2010 |
| CARISOPRODOL AND ASPIRIN (ANDA # 040832) |
000 |
ASPIRIN; CARISOPRODOL |
CONCORD LABS NJ |
Approval |
01/07/2010 |
| CETIRIZINE HYDROCHLORIDE (ANDA # 078617) |
000 |
CETIRIZINE HYDROCHLORIDE |
ACTAVIS MID ATLANTIC |
Approval |
02/02/2010 |
| CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY (ANDA # 090750) |
000 |
CETIRIZINE HYDROCHLORIDE |
AUROBINDO PHARMA |
Approval |
02/02/2010 |
| CHILDREN\'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF (ANDA # 090750) |
000 |
CETIRIZINE HYDROCHLORIDE |
AUROBINDO PHARMA |
Approval |
02/02/2010 |
| IBANDRONATE SODIUM (ANDA # 078998) |
000 |
IBANDRONATE SODIUM |
ORCHID HLTHCARE |
Tentative Approval |
01/06/2010 |
| IBANDRONATE SODIUM (ANDA # 079002) |
000 |
IBANDRONATE SODIUM |
COBALT LABS INC |
Tentative Approval |
01/04/2010 |
| IBANDRONATE SODIUM (ANDA # 079003) |
000 |
IBANDRONATE SODIUM |
COBALT LABS INC |
Tentative Approval |
01/04/2010 |
| LABETALOL HYDROCLORIDE (ANDA # 079134) |
000 |
LABETALOL HYDROCHLORIDE |
SAGENT STRIDES |
Approval |
02/03/2010 |
