Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 212125
Company: TEVA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MICAFUNGIN SODIUM MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE;INTRAVENOUS None (Tentative Approval) None No No
MICAFUNGIN SODIUM MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE;INTRAVENOUS None (Tentative Approval) None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/25/2020 ORIG-1 Tentative Approval Type 5 - New Formulation or New Manufacturer STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212125Orig1s000TAltr.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English