|
| ANDA Number
| DRUG NAME
| APPLICANT
| TENTATIVE Approval Date
|
| 1 |
75-669 |
FAMOTIDINE INJECTION, 10 MG/ML (PRESERVATIVE-FREE) |
FAULDING PHARMACEUTICAL CO |
12/12/00 |
| 2 |
75-705 |
FAMOTIDINE INJECTION, 10 MG/ ML (MULTIPLE-DOSE) |
FAULDING PHARMACEUTICAL CO. |
12/12/00 |
| 3 |
75-758 |
FAMOTIDINE TABLETS USP, 10 MG (OTC) |
CHEMINOR DRUGS LIMITED |
12/13/00 |
| 4 |
75-828 |
LOVASTATIN TABLETS USP, 10 MG, 20 MG, 40 MG |
PUREPAC PHARMACEUTICAL CO. |
12/19/00 |
| 5 |
75-486 |
FAMOTIDINE INJECTION, 10 MG/ML (PRESERVATIVE-FREE) |
ESI LEDERLE |
12/20/00 |
| 6 |
75-488 |
FAMOTIDINE INJECTION, 10 MG/ML (MULTIPLE-DOSE) |
ESI LEDERLE |
12/20/00 |
| 7 |
75-593 |
CIPROFLOXACIN TABLETS USP, 100 MG, 250 MG, 500 MG, 750 MG |
DANBURY PHARMACAL, INC. |
12/22/00 |
| 8 |
75-622 |
FAMOTIDINE INJECTION, 10 MG/ML (PRESERVATIVE-FREE) |
BEDFORD LABORATORIES |
12/26/00 |
