June 22, 2008 - 5:02pm
First-Time Generic Approvals - May 2008
Tablets/Capsules Only
| Generic Drug Name |
Generic Manufacturer |
Referenced Brand Name |
Approval Date |
Pill Identification |
|---|---|---|---|---|
| ROPINIROLE HYDROCHLORIDE TABLETS, 0.25 MG, 0.5 MG, 1
MG, 2 MG, 3 MG AND 4 MG |
MYLAN | REQUIP TABLETS | 05-05-08 | 2.5 mg - round white M N25; 0.5 mg - round yellow M N5; 1 mg - round green M N10; 2 mg - round orange M N20; 3 mg - round lavender M N30; 4 mg - grayish beige M N40 |
| ROPINIROLE HYDROCHLORIDE TABLETS, 0.25 MG, 0.5 MG, 1
MG, 2 MG, 3 MG AND 4 MG |
ROXANE | REQUIP TABLETS | 05-05-08 | 2.5 mg - round white 54 511; 0.5 mg - round yellow 54 337; 1 mg - round green 54 751; 2 mg - round orange 54 231; 3 mg - round red 54 575; 4 mg - round brown 54 273 |
| ACARBOSE TABLETS, 25 MG, 50 MG, AND 100 MG | COBALT | PRECOSE TABLET | 05-07-08 | |
| DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS, 3 MG/0.03 MG; (28-DAY
REGIMEN) |
BARR | YASMIN TALBETS | 05-09-08 | |
| FLUOXETINE CAPSULES, USP 10 MG AND 20 MG | TEVA | SARAFEM PULVULES, 10 MG AND 20 MG | 05-27-08 | 10 mg - purple capsule 93 7225; 20 mg - purple & flesh capsule 93 7226 |
| OMEPRAZOLE DELAYED-RELEASE CAPSULES USP, 10 MG, 20 MG AND 40 MG | ANDRX | PRILOSEC DELAYED-RELEASE CAPSULES | 05-30-08 |
