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 203448

KAITLIB FE (ETHINYL ESTRADIOL; NORETHINDRONE)
0.025MG;0.8MG
Marketing Status: Prescription
Active Ingredient: ETHINYL ESTRADIOL; NORETHINDRONE
Proprietary Name: KAITLIB FE
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: 0.025MG;0.8MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A203448
Product Number: 001
Approval Date: Dec 17, 2015
Applicant Holder Full Name: LUPIN LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
Back to Top