نیکاردیپین هیدروکلراید (Nicardipine Hydrochloride)
۵۳ محصول ثبت‌شده نسخه‌ای ANDANDA
خلاصهٔ ثبت FDA
- فرم‌های دارویی
- CAPSULE;ORAL · INJECTABLE;INJECTION · INJECTABLE;INTRAVENOUS
- دوزهای ثبت‌شده
- 25MG/10ML (2.5MG/ML) · 30MG · 20MG · 20MG/200ML (0.1MG/ML)
- شرکت‌های دارنده
- CHIESI · ANI PHARMS · HIKMA INTL PHARMS · AMNEAL
- پروندهٔ رسمی
- 019734
محصولات ثبت‌شده (۵۳ مورد)
| نام محصول | فرم | دوز | شرکت | نوع | وضعیت | پرونده |
|---|---|---|---|---|---|---|
| CARDENE | CAPSULE;ORAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CHIESI | NDA | متوقف‌شده | 019488 |
| CARDENE | CAPSULE;ORAL | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CHIESI | NDA | متوقف‌شده | 019488 |
| CARDENE | INJECTABLE;INJECTION | 25MG/10ML (2.5MG/ML) | CHIESI | NDA | نسخه‌ای | 019734 |
| CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER | INJECTABLE;INTRAVENOUS | 20MG/200ML (0.1MG/ML) | CHIESI | NDA | نسخه‌ای | 019734 |
| CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER | INJECTABLE;INTRAVENOUS | 20MG/200ML (0.1MG/ML) | CHIESI | NDA | نسخه‌ای | 019734 |
| CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER | INJECTABLE;INTRAVENOUS | 40MG/200ML (0.2MG/ML) | CHIESI | NDA | نسخه‌ای | 019734 |
| CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER | INJECTABLE;INTRAVENOUS | 40MG/200ML (0.2MG/ML) | CHIESI | NDA | متوقف‌شده | 019734 |
| CARDENE SR | CAPSULE, EXTENDED RELEASE;ORAL | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CHIESI | NDA | متوقف‌شده | 020005 |
| CARDENE SR | CAPSULE, EXTENDED RELEASE;ORAL | 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CHIESI | NDA | متوقف‌شده | 020005 |
| CARDENE SR | CAPSULE, EXTENDED RELEASE;ORAL | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CHIESI | NDA | متوقف‌شده | 020005 |
| NICARDIPINE HYDROCHLORIDE | INJECTABLE;INJECTION | 25MG/10ML (2.5MG/ML) | HIKMA INTL PHARMS | NDA | نسخه‌ای | 022276 |
| NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE | INJECTABLE;INTRAVENOUS | 20MG/200ML (0.1MG/ML) | HIKMA INTL PHARMS | NDA | نسخه‌ای | 022276 |
| NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE | INJECTABLE;INTRAVENOUS | 40MG/200ML (0.2MG/ML) | HIKMA INTL PHARMS | NDA | نسخه‌ای | 022276 |
| NICARDIPINE HYDROCHLORIDE | CAPSULE;ORAL | 20MG | ANI PHARMS | ANDA | متوقف‌شده | 074439 |
| NICARDIPINE HYDROCHLORIDE | CAPSULE;ORAL | 30MG | ANI PHARMS | ANDA | متوقف‌شده | 074439 |
| NICARDIPINE HYDROCHLORIDE | CAPSULE;ORAL | 20MG | ANI PHARMS | ANDA | متوقف‌شده | 074540 |
| NICARDIPINE HYDROCHLORIDE | CAPSULE;ORAL | 30MG | ANI PHARMS | ANDA | متوقف‌شده | 074540 |
| NICARDIPINE HYDROCHLORIDE | CAPSULE;ORAL | 20MG | PHARMOBEDIENT | ANDA | متوقف‌شده | 074642 |
| NICARDIPINE HYDROCHLORIDE | CAPSULE;ORAL | 30MG | PHARMOBEDIENT | ANDA | متوقف‌شده | 074642 |
| NICARDIPINE HYDROCHLORIDE | CAPSULE;ORAL | 20MG | ANI PHARMS | ANDA | نسخه‌ای | 074670 |
| NICARDIPINE HYDROCHLORIDE | CAPSULE;ORAL | 30MG | ANI PHARMS | ANDA | نسخه‌ای | 074670 |
| NICARDIPINE HYDROCHLORIDE | CAPSULE;ORAL | 20MG | EPIC PHARMA LLC | ANDA | نسخه‌ای | 074928 |
| NICARDIPINE HYDROCHLORIDE | CAPSULE;ORAL | 30MG | EPIC PHARMA LLC | ANDA | نسخه‌ای | 074928 |
| NICARDIPINE HYDROCHLORIDE | INJECTABLE;INJECTION | 25MG/10ML (2.5MG/ML) | SUN PHARM | NDA | متوقف‌شده | 078405 |
| NICARDIPINE HYDROCHLORIDE | INJECTABLE;INJECTION | 25MG/10ML (2.5MG/ML) | HIKMA | ANDA | متوقف‌شده | 078714 |
| NICARDIPINE HYDROCHLORIDE | INJECTABLE;INJECTION | 25MG/10ML (2.5MG/ML) | NAVINTA LLC | ANDA | متوقف‌شده | 090125 |
| NICARDIPINE HYDROCHLORIDE | INJECTABLE;INJECTION | 25MG/10ML (2.5MG/ML) | AM REGENT | ANDA | نسخه‌ای | 090534 |
| NICARDIPINE HYDROCHLORIDE | INJECTABLE;INJECTION | 25MG/10ML (2.5MG/ML) | SOMERSET THERAPS LLC | ANDA | نسخه‌ای | 090664 |
| NICARDIPINE HYDROCHLORIDE | INJECTABLE;INJECTION | 25MG/10ML (2.5MG/ML) | MANKIND PHARMA | ANDA | نسخه‌ای | 090671 |
| NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE | INJECTABLE;INTRAVENOUS | 20MG/200ML (0.1MG/ML) | INFORLIFE | ANDA | نسخه‌ای | 203978 |
| NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE | INJECTABLE;INTRAVENOUS | 40MG/200ML (0.2MG/ML) | INFORLIFE | ANDA | نسخه‌ای | 203978 |
| NICARDIPINE HYDROCHLORIDE | INJECTABLE;INJECTION | 25MG/10ML (2.5MG/ML) | EUGIA PHARMA | ANDA | نسخه‌ای | 211121 |
| NICARDIPINE HYDROCHLORIDE | CAPSULE;ORAL | 20MG | PHARMAZONE | ANDA | نسخه‌ای | 215377 |
| NICARDIPINE HYDROCHLORIDE | CAPSULE;ORAL | 30MG | PHARMAZONE | ANDA | نسخه‌ای | 215377 |
| NICARDIPINE HYDROCHLORIDE | INJECTABLE;INJECTION | 25MG/10ML (2.5MG/ML) | AMNEAL | ANDA | متوقف‌شده | 215406 |
| NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE | INJECTABLE;INTRAVENOUS | 20MG/200ML (0.1MG/ML) | CIPLA | ANDA | نسخه‌ای | 215592 |
| NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE | INJECTABLE;INTRAVENOUS | 40MG/200ML (0.2MG/ML) | CIPLA | ANDA | نسخه‌ای | 215592 |
| NICARDIPINE HYDROCHLORIDE | CAPSULE;ORAL | 20MG | GLENMARK PHARMS LTD | ANDA | نسخه‌ای | 216357 |
| NICARDIPINE HYDROCHLORIDE | CAPSULE;ORAL | 30MG | GLENMARK PHARMS LTD | ANDA | نسخه‌ای | 216357 |
| NICARDIPINE HYDROCHLORIDE | INJECTABLE;INJECTION | 25MG/10ML (2.5MG/ML) | MICRO LABS | ANDA | نسخه‌ای | 216420 |
| NICARDIPINE HYDROCHLORIDE | INJECTABLE;INJECTION | 25MG/10ML (2.5MG/ML) | NANJING KING FRIEND | ANDA | نسخه‌ای | 216819 |
| NICARDIPINE HYDROCHLORIDE | INJECTABLE;INJECTION | 25MG/10ML (2.5MG/ML) | CHENGDU SHUODE | ANDA | نسخه‌ای | 217548 |
| NICARDIPINE HYDROCHLORIDE | CAPSULE;ORAL | 20MG | BIONPHARMA | ANDA | نسخه‌ای | 217555 |
| NICARDIPINE HYDROCHLORIDE | CAPSULE;ORAL | 30MG | BIONPHARMA | ANDA | نسخه‌ای | 217555 |
| NICARDIPINE HYDROCHLORIDE | CAPSULE;ORAL | 20MG | AMNEAL | ANDA | نسخه‌ای | 218202 |
| NICARDIPINE HYDROCHLORIDE | CAPSULE;ORAL | 30MG | AMNEAL | ANDA | نسخه‌ای | 218202 |
| NICARDIPINE HYDROCHLORIDE | CAPSULE;ORAL | 20MG | CHARTWELL RX | ANDA | متوقف‌شده | 218638 |
| NICARDIPINE HYDROCHLORIDE | CAPSULE;ORAL | 30MG | CHARTWELL RX | ANDA | متوقف‌شده | 218638 |
| NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE | INJECTABLE;INTRAVENOUS | 20MG/200ML (0.1MG/ML) | FRESENIUS KABI USA | ANDA | نسخه‌ای | 219334 |
| NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE | INJECTABLE;INTRAVENOUS | 40MG/200ML (0.2MG/ML) | FRESENIUS KABI USA | ANDA | نسخه‌ای | 219334 |
| NICARDIPINE HYDROCHLORIDE | INJECTABLE;INJECTION | 25MG/10ML (2.5MG/ML) | QILU PHARM HAINAN | ANDA | نسخه‌ای | 219608 |
| NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE | INJECTABLE;INTRAVENOUS | 20MG/200ML (0.1MG/ML) | CAPLIN | ANDA | نسخه‌ای | 220243 |
| NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE | INJECTABLE;INTRAVENOUS | 40MG/200ML (0.2MG/ML) | CAPLIN | ANDA | نسخه‌ای | 220243 |
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