Orange Book product

CHABELINA FE 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG

Orange Book ANDA 202962 · NOVAST LABORATORIES LTD · Prescription

Key facts

Proprietary name CHABELINA FE
Active ingredients ETHINYL ESTRADIOL, NORETHINDRONE ACETATE
Strength 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG
Dosage form TABLET
Route ORAL-28
Application ANDA202962
Applicant holder NOVAST LABORATORIES LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date Apr 15, 2020

At a glance

  • 1–9 Marketed products with the same ingredient, strength and form
  • 1–9 Products in this application
  • No Reference listed drug

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Orange Book products

The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.

Source: U.S. Food and Drug Administration (FDA), Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)

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