نالوکسان هیدروکلراید (Naloxone Hydrochloride)
۹۹ محصول ثبتشده متوقفشده ANDANDA
خلاصهٔ ثبت FDA
- فرمهای دارویی
- INJECTABLE;INJECTION · SPRAY, METERED;NASAL · SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS
- دوزهای ثبتشده
- 0.4MG/ML · 1MG/ML · 0.02MG/ML · 4MG/SPRAY
- شرکتهای دارنده
- IGI LABS INC · HIKMA · HOSPIRA · WYETH AYERST
- پروندهٔ رسمی
- 016636
محصولات ثبتشده (نمایش ۸۰ از ۹۹)
| نام محصول | فرم | دوز | شرکت | نوع | وضعیت | پرونده |
|---|---|---|---|---|---|---|
| NARCAN | INJECTABLE;INJECTION | 0.4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ADAPT | NDA | متوقفشده | 016636 |
| NARCAN | INJECTABLE;INJECTION | 0.02MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ADAPT | NDA | متوقفشده | 016636 |
| NARCAN | INJECTABLE;INJECTION | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ADAPT | NDA | متوقفشده | 016636 |
| NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.02MG/ML | HOSPIRA | ANDA | متوقفشده | 070171 |
| NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.4MG/ML | HOSPIRA | ANDA | نسخهای | 070172 |
| NALOXONE | INJECTABLE;INJECTION | 0.02MG/ML | WYETH AYERST | ANDA | متوقفشده | 070188 |
| NALOXONE | INJECTABLE;INJECTION | 0.02MG/ML | WYETH AYERST | ANDA | متوقفشده | 070189 |
| NALOXONE | INJECTABLE;INJECTION | 0.4MG/ML | WYETH AYERST | ANDA | متوقفشده | 070190 |
| NALOXONE | INJECTABLE;INJECTION | 0.4MG/ML | WYETH AYERST | ANDA | متوقفشده | 070191 |
| NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.02MG/ML | HOSPIRA | ANDA | متوقفشده | 070252 |
| NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.02MG/ML | HOSPIRA | ANDA | متوقفشده | 070253 |
| NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.4MG/ML | HOSPIRA | ANDA | متوقفشده | 070254 |
| NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.4MG/ML | HOSPIRA | ANDA | متوقفشده | 070255 |
| NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.4MG/ML | HOSPIRA | ANDA | نسخهای | 070256 |
| NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.4MG/ML | HOSPIRA | ANDA | نسخهای | 070257 |
| NALOXONE | INJECTABLE;INJECTION | 0.4MG/ML | HIKMA | ANDA | متوقفشده | 070298 |
| NALOXONE | INJECTABLE;INJECTION | 0.4MG/ML | HIKMA | ANDA | نسخهای | 070299 |
| NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.4MG/ML | INTL MEDICATION | ANDA | متوقفشده | 070417 |
| NALOXONE | INJECTABLE;INJECTION | 0.4MG/ML | HIKMA | ANDA | متوقفشده | 070496 |
| NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.4MG/ML | INTL MEDICATION | ANDA | متوقفشده | 070639 |
| NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.02MG/ML | ABRAXIS PHARM | ANDA | متوقفشده | 070648 |
| NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.4MG/ML | ABRAXIS PHARM | ANDA | متوقفشده | 070649 |
| NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.02MG/ML | ABRAXIS PHARM | ANDA | متوقفشده | 070661 |
| NALOXONE HCL | Injectable;Injection | 0.02MG/ML | QUAD PHARMS | ANDA | متوقفشده | 070678 |
| NALOXONE HCL | Injectable;Injection | 0.4MG/ML | QUAD PHARMS | ANDA | متوقفشده | 070679 |
| NALOXONE HCL | Injectable;Injection | 1MG/ML | QUAD PHARMS | ANDA | متوقفشده | 070680 |
| NARCAN | INJECTABLE;INJECTION | 0.4MG/ML | BRISTOL MYERS SQUIBB | ANDA | متوقفشده | 071083 |
| NARCAN | INJECTABLE;INJECTION | 1MG/ML | BRISTOL MYERS SQUIBB | ANDA | متوقفشده | 071084 |
| NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.02MG/ML | HIKMA | ANDA | متوقفشده | 071272 |
| NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 1MG/ML | HIKMA | ANDA | متوقفشده | 071273 |
| NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 1MG/ML | HIKMA | ANDA | متوقفشده | 071274 |
| NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 1MG/ML | HIKMA | ANDA | متوقفشده | 071287 |
| NARCAN | INJECTABLE;INJECTION | 1MG/ML | BRISTOL MYERS SQUIBB | ANDA | متوقفشده | 071311 |
| NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.4MG/ML | WATSON LABS | ANDA | متوقفشده | 071339 |
| NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 1MG/ML | ABRAXIS PHARM | ANDA | متوقفشده | 071604 |
| NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.02MG/ML | SMITH AND NEPHEW | ANDA | متوقفشده | 071671 |
| NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.02MG/ML | SOLOPAK | ANDA | متوقفشده | 071672 |
| NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.4MG/ML | SMITH AND NEPHEW | ANDA | متوقفشده | 071681 |
| NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.4MG/ML | SMITH AND NEPHEW | ANDA | متوقفشده | 071682 |
| NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.4MG/ML | SOLOPAK | ANDA | متوقفشده | 071683 |
| NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.4MG/ML | MARSAM PHARMS LLC | ANDA | متوقفشده | 071811 |
| NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 1MG/ML | INTL MEDICATION | ANDA | نسخهای | 072076 |
| NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.02MG/ML | ASTRAZENECA | ANDA | متوقفشده | 072081 |
| NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.02MG/ML | IGI LABS INC | ANDA | متوقفشده | 072082 |
| NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.02MG/ML | IGI LABS INC | ANDA | متوقفشده | 072083 |
| NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.02MG/ML | IGI LABS INC | ANDA | متوقفشده | 072084 |
| NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.02MG/ML | IGI LABS INC | ANDA | متوقفشده | 072085 |
| NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.4MG/ML | IGI LABS INC | ANDA | متوقفشده | 072086 |
| NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.4MG/ML | IGI LABS INC | ANDA | متوقفشده | 072087 |
| NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.4MG/ML | IGI LABS INC | ANDA | متوقفشده | 072088 |
| NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.4MG/ML | IGI LABS INC | ANDA | متوقفشده | 072089 |
| NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.4MG/ML | IGI LABS INC | ANDA | متوقفشده | 072090 |
| NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 1MG/ML | IGI LABS INC | ANDA | متوقفشده | 072091 |
| NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 1MG/ML | IGI LABS INC | ANDA | متوقفشده | 072092 |
| NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 1MG/ML | IGI LABS INC | ANDA | متوقفشده | 072093 |
| NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 1MG/ML | INTL MEDICATION | ANDA | متوقفشده | 072115 |
| NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.4MG/ML | MYLAN INSTITUTIONAL | ANDA | نسخهای | 204997 |
| NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.4MG/ML | MYLAN INSTITUTIONAL | ANDA | نسخهای | 205014 |
| EVZIO | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 0.4MG/0.4ML (0.4MG/0.4ML) | KALEO INC | NDA | متوقفشده | 205787 |
| NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.4MG/ML | SOMERSET THERAPS LLC | ANDA | نسخهای | 207633 |
| NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.4MG/ML | SOMERSET THERAPS LLC | ANDA | نسخهای | 207634 |
| NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.4MG/ML | CHARTWELL RX | ANDA | متوقفشده | 207846 |
| NARCAN | SPRAY, METERED;NASAL | 4MG/SPRAY | EMERGENT | NDA | بدون نسخه | 208411 |
| NARCAN | SPRAY, METERED;NASAL | 2MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | EMERGENT | NDA | متوقفشده | 208411 |
| NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.4MG/ML | RISING | ANDA | نسخهای | 208871 |
| NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.4MG/ML | RISING | ANDA | نسخهای | 208872 |
| REXTOVY | SPRAY, METERED;NASAL | 4MG/SPRAY | AMPHASTAR PHARMS INC | NDA | متوقفشده | 208969 |
| NALOXONE HYDROCHLORIDE | SPRAY, METERED;NASAL | 4MG/SPRAY | TEVA PHARMS USA | ANDA | بدون نسخه | 209522 |
| EVZIO (AUTOINJECTOR) | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 2MG/0.4ML (2MG/0.4ML) | KALEO INC | NDA | متوقفشده | 209862 |
| NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.4MG/ML | PH HEALTH | ANDA | متوقفشده | 211286 |
| NALOXONE HYDROCHLORIDE | SPRAY, METERED;NASAL | 4MG/SPRAY | PADAGIS ISRAEL | ANDA | بدون نسخه | 211951 |
| KLOXXADO | SPRAY;NASAL | 8MG/SPRAY | HIKMA | NDA | نسخهای | 212045 |
| KLOXXADO | SPRAY;NASAL | 4MG/SPRAY | HIKMA | NDA | متوقفشده | 212045 |
| NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 1MG/ML | HIKMA | ANDA | نسخهای | 212300 |
| NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.4MG/ML | HIKMA | ANDA | نسخهای | 212300 |
| NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.4MG/ML | EUGIA PHARMA | ANDA | متوقفشده | 212455 |
| NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.4MG/ML | EUGIA PHARMA | ANDA | نسخهای | 212456 |
| ZIMHI | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 5MG/0.5ML (5MG/0.5ML) | ZMI PHARMA | NDA | نسخهای | 212854 |
| NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 1MG/ML | DR REDDYS | ANDA | نسخهای | 213209 |
| NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 1MG/ML | EUGIA PHARMA | ANDA | نسخهای | 213279 |
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