لووفلوکساسین (Levofloxacin)
۱۱۷ محصول ثبتشده نسخهای ANDANDA
خلاصهٔ ثبت FDA
- فرمهای دارویی
- TABLET;ORAL · INJECTABLE;INJECTION · SOLUTION/DROPS;OPHTHALMIC
- دوزهای ثبتشده
- 250MG · 500MG · 750MG · 0.5%
- شرکتهای دارنده
- JANSSEN PHARMS · HOSPIRA · EUGIA PHARMA · GLAND
- پروندهٔ رسمی
- 020635
محصولات ثبتشده (نمایش ۸۰ از ۱۱۷)
| نام محصول | فرم | دوز | شرکت | نوع | وضعیت | پرونده |
|---|---|---|---|---|---|---|
| LEVAQUIN | TABLET;ORAL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | JANSSEN PHARMS | NDA | متوقفشده | 020634 |
| LEVAQUIN | TABLET;ORAL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | JANSSEN PHARMS | NDA | متوقفشده | 020634 |
| LEVAQUIN | TABLET;ORAL | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | JANSSEN PHARMS | NDA | متوقفشده | 020634 |
| LEVAQUIN | INJECTABLE;INJECTION | EQ 500MG/20ML (EQ 25MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | JANSSEN PHARMS | NDA | متوقفشده | 020635 |
| LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | INJECTABLE;INJECTION | EQ 250MG/50ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | JANSSEN PHARMS | NDA | متوقفشده | 020635 |
| LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | INJECTABLE;INJECTION | EQ 500MG/100ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | JANSSEN PHARMS | NDA | متوقفشده | 020635 |
| LEVAQUIN | INJECTABLE;INJECTION | EQ 750MG/30ML (EQ 25MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | JANSSEN PHARMS | NDA | متوقفشده | 020635 |
| LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | INJECTABLE;INJECTION | EQ 750MG/150ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | JANSSEN PHARMS | NDA | متوقفشده | 020635 |
| QUIXIN | SOLUTION/DROPS;OPHTHALMIC | 0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SANTEN | NDA | متوقفشده | 021199 |
| IQUIX | SOLUTION/DROPS;OPHTHALMIC | 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SANTEN | NDA | متوقفشده | 021571 |
| LEVAQUIN | SOLUTION;ORAL | 250MG/10ML | JANSSEN PHARMS | NDA | متوقفشده | 021721 |
| LEVOFLOXACIN | TABLET;ORAL | 250MG | NATCO PHARMA | ANDA | متوقفشده | 076276 |
| LEVOFLOXACIN | TABLET;ORAL | 500MG | NATCO PHARMA | ANDA | متوقفشده | 076276 |
| LEVOFLOXACIN | TABLET;ORAL | 250MG | TEVA | ANDA | نسخهای | 076361 |
| LEVOFLOXACIN | TABLET;ORAL | 500MG | TEVA | ANDA | نسخهای | 076361 |
| LEVOFLOXACIN | TABLET;ORAL | 750MG | TEVA | ANDA | نسخهای | 076361 |
| LEVOFLOXACIN | TABLET;ORAL | 250MG | DR REDDYS LABS INC | ANDA | نسخهای | 076710 |
| LEVOFLOXACIN | TABLET;ORAL | 500MG | DR REDDYS LABS INC | ANDA | نسخهای | 076710 |
| LEVOFLOXACIN | TABLET;ORAL | 750MG | DR REDDYS LABS INC | ANDA | نسخهای | 076710 |
| LEVOFLOXACIN | SOLUTION/DROPS;OPHTHALMIC | 0.5% | WATSON LABS TEVA | ANDA | متوقفشده | 076826 |
| LEVOFLOXACIN | TABLET;ORAL | 250MG | CHARTWELL MOLECULAR | ANDA | نسخهای | 076890 |
| LEVOFLOXACIN | TABLET;ORAL | 500MG | CHARTWELL MOLECULAR | ANDA | نسخهای | 076890 |
| LEVOFLOXACIN | TABLET;ORAL | 750MG | CHARTWELL MOLECULAR | ANDA | نسخهای | 076890 |
| LEVOFLOXACIN | TABLET;ORAL | 750MG | NATCO PHARMA | ANDA | متوقفشده | 077097 |
| LEVOFLOXACIN | TABLET;ORAL | 250MG | SANDOZ | ANDA | متوقفشده | 077438 |
| LEVOFLOXACIN | TABLET;ORAL | 500MG | SANDOZ | ANDA | متوقفشده | 077438 |
| LEVOFLOXACIN | TABLET;ORAL | 750MG | SANDOZ | ANDA | متوقفشده | 077438 |
| LEVOFLOXACIN | TABLET;ORAL | 250MG | ZYDUS LIFESCIENCES | ANDA | نسخهای | 077652 |
| LEVOFLOXACIN | TABLET;ORAL | 500MG | ZYDUS LIFESCIENCES | ANDA | نسخهای | 077652 |
| LEVOFLOXACIN | TABLET;ORAL | 750MG | ZYDUS LIFESCIENCES | ANDA | نسخهای | 077652 |
| LEVOFLOXACIN | SOLUTION/DROPS;OPHTHALMIC | 0.5% | RISING | ANDA | نسخهای | 077700 |
| LEVOFLOXACIN | SOLUTION/DROPS;OPHTHALMIC | 0.5% | RUBICON RESEARCH | ANDA | نسخهای | 078282 |
| LEVOFLOXACIN | TABLET;ORAL | 250MG | LUPIN | ANDA | متوقفشده | 078424 |
| LEVOFLOXACIN | TABLET;ORAL | 500MG | LUPIN | ANDA | متوقفشده | 078424 |
| LEVOFLOXACIN | TABLET;ORAL | 750MG | LUPIN | ANDA | متوقفشده | 078424 |
| LEVOFLOXACIN | INJECTABLE;INJECTION | EQ 500MG/20ML (EQ 25MG/ML) | HOSPIRA | ANDA | متوقفشده | 078577 |
| LEVOFLOXACIN | INJECTABLE;INJECTION | EQ 750MG/30ML (EQ 25MG/ML) | HOSPIRA | ANDA | متوقفشده | 078577 |
| LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | INJECTABLE;INJECTION | EQ 250MG/50ML (EQ 5MG/ML) | HOSPIRA | ANDA | نسخهای | 078579 |
| LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | INJECTABLE;INJECTION | EQ 500MG/100ML (EQ 5MG/ML) | HOSPIRA | ANDA | نسخهای | 078579 |
| LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | INJECTABLE;INJECTION | EQ 750MG/150ML (EQ 5MG/ML) | HOSPIRA | ANDA | نسخهای | 078579 |
| LEVOFLOXACIN | TABLET;ORAL | 250MG | HIKMA PHARMS | ANDA | تأیید مشروط | 078767 |
| LEVOFLOXACIN | TABLET;ORAL | 500MG | HIKMA PHARMS | ANDA | تأیید مشروط | 078767 |
| LEVOFLOXACIN | TABLET;ORAL | 750MG | HIKMA PHARMS | ANDA | تأیید مشروط | 078767 |
| LEVOFLOXACIN | TABLET;ORAL | 250MG | MYLAN PHARMA | ANDA | تأیید مشروط | 090063 |
| LEVOFLOXACIN | TABLET;ORAL | 500MG | MYLAN PHARMA | ANDA | تأیید مشروط | 090063 |
| LEVOFLOXACIN | TABLET;ORAL | 750MG | MYLAN PHARMA | ANDA | تأیید مشروط | 090063 |
| LEVOFLOXACIN | SOLUTION/DROPS;OPHTHALMIC | 0.5% | SCIEGEN PHARMS | ANDA | متوقفشده | 090268 |
| LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | INJECTABLE;INJECTION | EQ 250MG/50ML (EQ 5MG/ML) | INFORLIFE | ANDA | نسخهای | 090343 |
| LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | INJECTABLE;INJECTION | EQ 500MG/100ML (EQ 5MG/ML) | INFORLIFE | ANDA | نسخهای | 090343 |
| LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | INJECTABLE;INJECTION | EQ 750MG/150ML (EQ 5MG/ML) | INFORLIFE | ANDA | نسخهای | 090343 |
| LEVOFLOXACIN | TABLET;ORAL | 250MG | CHARTWELL RX | ANDA | متوقفشده | 090367 |
| LEVOFLOXACIN | TABLET;ORAL | 500MG | CHARTWELL RX | ANDA | متوقفشده | 090367 |
| LEVOFLOXACIN | TABLET;ORAL | 750MG | CHARTWELL RX | ANDA | متوقفشده | 090367 |
| LEVOFLOXACIN | TABLET;ORAL | 250MG | TORRENT PHARMS | ANDA | متوقفشده | 090722 |
| LEVOFLOXACIN | TABLET;ORAL | 500MG | TORRENT PHARMS | ANDA | متوقفشده | 090722 |
| LEVOFLOXACIN | TABLET;ORAL | 750MG | TORRENT PHARMS | ANDA | متوقفشده | 090722 |
| LEVOFLOXACIN | TABLET;ORAL | 250MG | APOTEX INC | ANDA | متوقفشده | 090787 |
| LEVOFLOXACIN | TABLET;ORAL | 500MG | APOTEX INC | ANDA | متوقفشده | 090787 |
| LEVOFLOXACIN | TABLET;ORAL | 750MG | APOTEX INC | ANDA | متوقفشده | 090787 |
| LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | INJECTABLE;INJECTION | EQ 250MG/50ML (EQ 5MG/ML) | HIKMA FARMACEUTICA | ANDA | نسخهای | 091375 |
| LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | INJECTABLE;INJECTION | EQ 500MG/100ML (EQ 5MG/ML) | HIKMA FARMACEUTICA | ANDA | نسخهای | 091375 |
| LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | INJECTABLE;INJECTION | EQ 750MG/150ML (EQ 5MG/ML) | HIKMA FARMACEUTICA | ANDA | نسخهای | 091375 |
| LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | INJECTABLE;INJECTION | EQ 250MG/50ML (EQ 5MG/ML) | BAXTER HLTHCARE CORP | ANDA | متوقفشده | 091397 |
| LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | INJECTABLE;INJECTION | EQ 500MG/100ML (EQ 5MG/ML) | BAXTER HLTHCARE CORP | ANDA | متوقفشده | 091397 |
| LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | INJECTABLE;INJECTION | EQ 750MG/150ML (EQ 5MG/ML) | BAXTER HLTHCARE CORP | ANDA | متوقفشده | 091397 |
| LEVOFLOXACIN | INJECTABLE;INJECTION | EQ 500MG/20ML (EQ 25MG/ML) | BAXTER HLTHCARE CORP | ANDA | متوقفشده | 091436 |
| LEVOFLOXACIN | INJECTABLE;INJECTION | EQ 500MG/20ML (EQ 25MG/ML) | RISING | ANDA | نسخهای | 091644 |
| LEVOFLOXACIN | INJECTABLE;INJECTION | EQ 750MG/30ML (EQ 25MG/ML) | RISING | ANDA | نسخهای | 091644 |
| LEVOFLOXACIN | SOLUTION;ORAL | 250MG/10ML | NOVITIUM PHARMA | ANDA | نسخهای | 091678 |
| LEVOFLOXACIN | TABLET;ORAL | 250MG | GLENMARK PHARMS LTD | ANDA | نسخهای | 200250 |
| LEVOFLOXACIN | TABLET;ORAL | 500MG | GLENMARK PHARMS LTD | ANDA | نسخهای | 200250 |
| LEVOFLOXACIN | TABLET;ORAL | 750MG | GLENMARK PHARMS LTD | ANDA | نسخهای | 200250 |
| LEVOFLOXACIN | INJECTABLE;INJECTION | EQ 500MG/20ML (EQ 25MG/ML) | PHARMOBEDIENT | ANDA | متوقفشده | 200560 |
| LEVOFLOXACIN | INJECTABLE;INJECTION | EQ 750MG/30ML (EQ 25MG/ML) | PHARMOBEDIENT | ANDA | متوقفشده | 200560 |
| LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | INJECTABLE;INJECTION | EQ 250MG/50ML (EQ 5MG/ML) | FRESENIUS KABI USA | ANDA | نسخهای | 200674 |
| LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | INJECTABLE;INJECTION | EQ 500MG/100ML (EQ 5MG/ML) | FRESENIUS KABI USA | ANDA | نسخهای | 200674 |
| LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | INJECTABLE;INJECTION | EQ 750MG/150ML (EQ 5MG/ML) | FRESENIUS KABI USA | ANDA | نسخهای | 200674 |
| LEVOFLOXACIN | TABLET;ORAL | 250MG | MACLEODS PHARMS LTD | ANDA | نسخهای | 200839 |
| LEVOFLOXACIN | TABLET;ORAL | 500MG | MACLEODS PHARMS LTD | ANDA | نسخهای | 200839 |
| LEVOFLOXACIN | TABLET;ORAL | 750MG | MACLEODS PHARMS LTD | ANDA | نسخهای | 200839 |
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