هیدرومورفون هیدروکلراید (Hydromorphone Hydrochloride)
۷۶ محصول ثبت‌شده نسخه‌ای ANDANDA
خلاصهٔ ثبت FDA
- فرم‌های دارویی
- INJECTABLE;INJECTION · TABLET;ORAL · TABLET, EXTENDED RELEASE;ORAL
- دوزهای ثبت‌شده
- 8MG · 4MG · 10MG/ML · 2MG
- شرکت‌های دارنده
- HIKMA · ASCENT PHARMS INC · FRESENIUS KABI USA · SPECGX LLC
- پروندهٔ رسمی
- 019034
محصولات ثبت‌شده (۷۶ مورد)
| نام محصول | فرم | دوز | شرکت | نوع | وضعیت | پرونده |
|---|---|---|---|---|---|---|
| DILAUDID-HP | INJECTABLE;INJECTION | 10MG/ML | FRESENIUS KABI USA | NDA | نسخه‌ای | 019034 |
| DILAUDID-HP | INJECTABLE;INJECTION | 250MG/VIAL | FRESENIUS KABI USA | NDA | متوقف‌شده | 019034 |
| DILAUDID | INJECTABLE;INJECTION | 1MG/ML | FRESENIUS KABI USA | NDA | نسخه‌ای | 019034 |
| DILAUDID | INJECTABLE;INJECTION | 2MG/ML | FRESENIUS KABI USA | NDA | نسخه‌ای | 019034 |
| DILAUDID | INJECTABLE;INJECTION | 4MG/ML | FRESENIUS KABI USA | NDA | نسخه‌ای | 019034 |
| DILAUDID | INJECTABLE;INJECTION | 0.2MG/ML | FRESENIUS KABI USA | NDA | نسخه‌ای | 019034 |
| DILAUDID | INJECTABLE;INJECTION | 0.5MG/0.5ML | FRESENIUS KABI USA | NDA | نسخه‌ای | 019034 |
| DILAUDID | SOLUTION;ORAL | 5MG/5ML | RHODES PHARMS | NDA | نسخه‌ای | 019891 |
| DILAUDID | TABLET;ORAL | 8MG | RHODES PHARMS | NDA | نسخه‌ای | 019892 |
| DILAUDID | TABLET;ORAL | 4MG | RHODES PHARMS | NDA | نسخه‌ای | 019892 |
| DILAUDID | TABLET;ORAL | 2MG | RHODES PHARMS | NDA | نسخه‌ای | 019892 |
| PALLADONE | CAPSULE, EXTENDED RELEASE;ORAL | 12MG | PURDUE PHARMA LP | NDA | متوقف‌شده | 021044 |
| PALLADONE | CAPSULE, EXTENDED RELEASE;ORAL | 16MG | PURDUE PHARMA LP | NDA | متوقف‌شده | 021044 |
| PALLADONE | CAPSULE, EXTENDED RELEASE;ORAL | 24MG | PURDUE PHARMA LP | NDA | متوقف‌شده | 021044 |
| PALLADONE | CAPSULE, EXTENDED RELEASE;ORAL | 32MG | PURDUE PHARMA LP | NDA | متوقف‌شده | 021044 |
| EXALGO | TABLET, EXTENDED RELEASE;ORAL | 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPECGX LLC | NDA | متوقف‌شده | 021217 |
| EXALGO | TABLET, EXTENDED RELEASE;ORAL | 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPECGX LLC | NDA | متوقف‌شده | 021217 |
| EXALGO | TABLET, EXTENDED RELEASE;ORAL | 16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPECGX LLC | NDA | متوقف‌شده | 021217 |
| EXALGO | TABLET, EXTENDED RELEASE;ORAL | 32MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPECGX LLC | NDA | متوقف‌شده | 021217 |
| HYDROMORPHONE HYDROCHLORIDE | INJECTABLE;INJECTION | 10MG/ML | WATSON LABS | ANDA | متوقف‌شده | 074317 |
| HYDROMORPHONE HYDROCHLORIDE | TABLET;ORAL | 8MG | HIKMA | ANDA | متوقف‌شده | 074597 |
| HYDROMORPHONE HYDROCHLORIDE | TABLET;ORAL | 4MG | HIKMA | ANDA | متوقف‌شده | 074597 |
| HYDROMORPHONE HYDROCHLORIDE | INJECTABLE;INJECTION | 10MG/ML | HOSPIRA | ANDA | متوقف‌شده | 074598 |
| HYDROMORPHONE HYDROCHLORIDE | SOLUTION;ORAL | 5MG/5ML | HIKMA | ANDA | نسخه‌ای | 074653 |
| HYDROMORPHONE HYDROCHLORIDE | INJECTABLE;INJECTION | 10MG/ML | BARR | ANDA | متوقف‌شده | 076444 |
| HYDROMORPHONE HYDROCHLORIDE | TABLET;ORAL | 8MG | MPP PHARMA | ANDA | متوقف‌شده | 076723 |
| HYDROMORPHONE HYDROCHLORIDE | TABLET;ORAL | 8MG | SPECGX LLC | ANDA | نسخه‌ای | 076855 |
| HYDROMORPHONE HYDROCHLORIDE | TABLET;ORAL | 2MG | SPECGX LLC | ANDA | نسخه‌ای | 076855 |
| HYDROMORPHONE HYDROCHLORIDE | TABLET;ORAL | 4MG | SPECGX LLC | ANDA | نسخه‌ای | 076855 |
| HYDROMORPHONE HYDROCHLORIDE | TABLET;ORAL | 2MG | NESHER PHARMS | ANDA | متوقف‌شده | 077311 |
| HYDROMORPHONE HYDROCHLORIDE | TABLET;ORAL | 4MG | NESHER PHARMS | ANDA | متوقف‌شده | 077311 |
| HYDROMORPHONE HYDROCHLORIDE | TABLET;ORAL | 8MG | NESHER PHARMS | ANDA | متوقف‌شده | 077311 |
| HYDROMORPHONE HYDROCHLORIDE | TABLET;ORAL | 8MG | GENUS | ANDA | متوقف‌شده | 077471 |
| HYDROMORPHONE HYDROCHLORIDE | TABLET;ORAL | 2MG | GENUS | ANDA | متوقف‌شده | 077471 |
| HYDROMORPHONE HYDROCHLORIDE | TABLET;ORAL | 4MG | GENUS | ANDA | متوقف‌شده | 077471 |
| HYDROMORPHONE HYDROCHLORIDE | INJECTABLE;INJECTION | 10MG/ML | RISING | ANDA | نسخه‌ای | 078228 |
| HYDROMORPHONE HYDROCHLORIDE | INJECTABLE;INJECTION | 10MG/ML | RISING | ANDA | نسخه‌ای | 078261 |
| HYDROMORPHONE HYDROCHLORIDE | TABLET;ORAL | 2MG | LANNETT | ANDA | نسخه‌ای | 078439 |
| HYDROMORPHONE HYDROCHLORIDE | TABLET;ORAL | 4MG | LANNETT | ANDA | نسخه‌ای | 078439 |
| HYDROMORPHONE HYDROCHLORIDE | INJECTABLE;INJECTION | 10MG/ML | HOSPIRA INC | ANDA | نسخه‌ای | 078591 |
| HYDROMORPHONE HYDROCHLORIDE | INJECTABLE;INJECTION | 1MG/ML | HOSPIRA INC | NDA | نسخه‌ای | 200403 |
| HYDROMORPHONE HYDROCHLORIDE | INJECTABLE;INJECTION | 2MG/ML | HOSPIRA INC | NDA | نسخه‌ای | 200403 |
| HYDROMORPHONE HYDROCHLORIDE | INJECTABLE;INJECTION | 4MG/ML | HOSPIRA INC | NDA | نسخه‌ای | 200403 |
| HYDROMORPHONE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.5MG/0.5ML | HOSPIRA INC | NDA | نسخه‌ای | 200403 |
| HYDROMORPHONE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.25MG/0.5ML | HOSPIRA INC | NDA | نسخه‌ای | 200403 |
| HYDROMORPHONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 8MG | ACTAVIS LABS FL INC | ANDA | متوقف‌شده | 202144 |
| HYDROMORPHONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 12MG | ACTAVIS LABS FL INC | ANDA | متوقف‌شده | 202144 |
| HYDROMORPHONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 16MG | ACTAVIS LABS FL INC | ANDA | متوقف‌شده | 202144 |
| HYDROMORPHONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 32MG | ACTAVIS LABS FL INC | ANDA | متوقف‌شده | 202144 |
| HYDROMORPHONE HYDROCHLORIDE | INJECTABLE;INJECTION | 2MG/ML | HIKMA | ANDA | نسخه‌ای | 202159 |
| HYDROMORPHONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 8MG | PADAGIS US | ANDA | نسخه‌ای | 204278 |
| HYDROMORPHONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 12MG | PADAGIS US | ANDA | نسخه‌ای | 204278 |
| HYDROMORPHONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 16MG | PADAGIS US | ANDA | نسخه‌ای | 204278 |
| HYDROMORPHONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 32MG | PADAGIS US | ANDA | نسخه‌ای | 204278 |
| HYDROMORPHONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 8MG | OSMOTICA PHARM US | ANDA | نسخه‌ای | 205629 |
| HYDROMORPHONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 12MG | OSMOTICA PHARM US | ANDA | نسخه‌ای | 205629 |
| HYDROMORPHONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 16MG | OSMOTICA PHARM US | ANDA | نسخه‌ای | 205629 |
| HYDROMORPHONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 32MG | OSMOTICA PHARM US | ANDA | نسخه‌ای | 205629 |
| HYDROMORPHONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 24MG | OSMOTICA PHARM US | ANDA | نسخه‌ای | 205629 |
| HYDROMORPHONE HYDROCHLORIDE | TABLET;ORAL | 2MG | AUROLIFE PHARMA LLC | ANDA | نسخه‌ای | 205814 |
| HYDROMORPHONE HYDROCHLORIDE | TABLET;ORAL | 4MG | AUROLIFE PHARMA LLC | ANDA | نسخه‌ای | 205814 |
| HYDROMORPHONE HYDROCHLORIDE | TABLET;ORAL | 8MG | AUROLIFE PHARMA LLC | ANDA | نسخه‌ای | 205814 |
| HYDROMORPHONE HYDROCHLORIDE | SOLUTION;ORAL | 5MG/5ML | PAI HOLDINGS | ANDA | متوقف‌شده | 207108 |
| HYDROMORPHONE HYDROCHLORIDE | SOLUTION;ORAL | 5MG/5ML | ASCENT PHARMS INC | ANDA | نسخه‌ای | 210176 |
| HYDROMORPHONE HYDROCHLORIDE | TABLET;ORAL | 2MG | ASCENT PHARMS INC | ANDA | نسخه‌ای | 210506 |
| HYDROMORPHONE HYDROCHLORIDE | TABLET;ORAL | 4MG | ASCENT PHARMS INC | ANDA | نسخه‌ای | 210506 |
| HYDROMORPHONE HYDROCHLORIDE | TABLET;ORAL | 8MG | ASCENT PHARMS INC | ANDA | نسخه‌ای | 210506 |
| HYDROMORPHONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 8MG | ASCENT PHARMS INC | ANDA | نسخه‌ای | 212133 |
| HYDROMORPHONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 12MG | ASCENT PHARMS INC | ANDA | نسخه‌ای | 212133 |
| HYDROMORPHONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 16MG | ASCENT PHARMS INC | ANDA | نسخه‌ای | 212133 |
| HYDROMORPHONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 32MG | ASCENT PHARMS INC | ANDA | نسخه‌ای | 212133 |
| HYDROMORPHONE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.2MG/ML | HIKMA | ANDA | نسخه‌ای | 216899 |
| HYDROMORPHONE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.5MG/0.5ML | HIKMA | ANDA | نسخه‌ای | 216899 |
| HYDROMORPHONE HYDROCHLORIDE | INJECTABLE;INJECTION | 1MG/ML | HIKMA | ANDA | نسخه‌ای | 216899 |
| HYDROMORPHONE HYDROCHLORIDE | INJECTABLE;INJECTION | 2MG/ML | HIKMA | ANDA | نسخه‌ای | 216899 |
| HYDROMORPHONE HYDROCHLORIDE | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 40MG/20ML (2MG/ML) | HIKMA | NDA | نسخه‌ای | 217812 |
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