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규제 업데이트

FDA, EMA, TGA 및 글로벌 규제 동향

#Hospira ×

UPDATED
규제 업데이트
2026년 9월 27일•1분 읽기
FDA Approves ANDA 076233 for Paclitaxel Injection (Hospira)
The FDA granted approval for ANDA 076233, a Paclitaxel injectable (6 mg/mL) submitted by Hospira. Original approval 2002, labeling supplement 2007.
UPDATED
규제 업데이트
2026년 9월 19일•1분 읽기
FDA Approves Gemcitabine Injection (ANDA079183)
The FDA has approved the ANDA for gemcitabine injection (ANDA079183) from Hospira, Inc., with details on submission history and labeling updates.
UPDATED
규제 업데이트
2026년 9월 17일•1분 읽기
FDA Approves ANDA063264 for Amikacin Sulfate Injection
The FDA approved ANDA063264 for Amikacin Sulfate injectable by Hospira. The product is listed as discontinued and includes multiple labeling and manufacturing supplemental submissions.
UPDATED
규제 업데이트
2026년 9월 11일•1분 읽기
FDA Approves ANDA206517 for Aztreonam Injectable Products
FDA has approved Hospira's aztreonam injectable (1 g and 2 g vials) for intramuscular and intravenous use under ANDA206517.
UPDATED
규제 업데이트
2026년 9월 10일•1분 읽기
FDA Grants Approval for Metoprolol Tartrate Injectable (ANDA078085) by Hospira
The FDA has approved Hospira’s Metoprolol Tartrate injectable (ANDA078085), an intravenous prescription drug with a 1 mg/mL strength.
UPDATED
규제 업데이트
2026년 8월 24일•1분 읽기
FDA Approves Ondansetron Injectable (ANDA077473)
The FDA has approved ANDA077473 for ondansetron injectable, manufactured by Hospira, for intramuscular and intravenous use.