U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Orange Book Home

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 212862

PRETOMANID (PRETOMANID)
200MG
Marketing Status: Prescription
Active Ingredient: PRETOMANID
Proprietary Name: PRETOMANID
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N212862
Product Number: 001
Approval Date: Aug 14, 2019
Applicant Holder Full Name: MYLAN IRELAND LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
Back to Top