Orange Book product

SEASONIQUE 0.03MG,0.01MG;0.15MG,N/A

Orange Book NDA 021840 · TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC · Prescription

Key facts

Proprietary name SEASONIQUE
Active ingredients ETHINYL ESTRADIOL, LEVONORGESTREL
Strength 0.03MG,0.01MG;0.15MG,N/A
Dosage form TABLET
Route ORAL
Application NDA021840
Applicant holder TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) Yes
Reference standard (RS) Yes
Approval date May 25, 2006

At a glance

  • 1–9 Marketed products with the same ingredient, strength and form
  • 1–9 Products in this application
  • Yes 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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