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 ANDA 209592

Expand all

BACLOFEN (BACLOFEN)
0.5MG/ML
Marketing Status: Prescription
Active Ingredient: BACLOFEN
Proprietary Name: BACLOFEN
Dosage Form; Route of Administration: INJECTABLE; INTRATHECAL
Strength: 0.5MG/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A209592
Product Number: 001
Approval Date: Mar 21, 2018
Applicant Holder Full Name: MYLAN LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
BACLOFEN (BACLOFEN)
2MG/ML
Marketing Status: Prescription
Active Ingredient: BACLOFEN
Proprietary Name: BACLOFEN
Dosage Form; Route of Administration: INJECTABLE; INTRATHECAL
Strength: 2MG/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A209592
Product Number: 002
Approval Date: Mar 21, 2018
Applicant Holder Full Name: MYLAN LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
Back to Top