Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 213660
Company: ZYDUS PHARMS USA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BREXPIPRAZOLE BREXPIPRAZOLE 0.25MG TABLET;ORAL None (Tentative Approval) None No No
BREXPIPRAZOLE BREXPIPRAZOLE 0.5MG TABLET;ORAL None (Tentative Approval) None No No
BREXPIPRAZOLE BREXPIPRAZOLE 1MG TABLET;ORAL None (Tentative Approval) None No No
BREXPIPRAZOLE BREXPIPRAZOLE 2MG TABLET;ORAL None (Tentative Approval) None No No
BREXPIPRAZOLE BREXPIPRAZOLE 3MG TABLET;ORAL None (Tentative Approval) None No No
BREXPIPRAZOLE BREXPIPRAZOLE 4MG TABLET;ORAL 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
09/08/2021 ORIG-1 Tentative Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213660Orig1s000TAltr.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