U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 216284
Company: ZYDUS LIFESCIENCES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXAMETHASONE DEXAMETHASONE 1MG TABLET;ORAL Prescription AB 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
05/09/2024 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216284Orig1s000TAltr.pdf

DEXAMETHASONE

TABLET;ORAL; 1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXAMETHASONE DEXAMETHASONE 1MG TABLET;ORAL Prescription No AB 217695 APOTEX
DEXAMETHASONE DEXAMETHASONE 1MG TABLET;ORAL Prescription Yes AB 088306 HIKMA
DEXAMETHASONE DEXAMETHASONE 1MG TABLET;ORAL Prescription No AB 216284 ZYDUS LIFESCIENCES
Back to Top