Orange Book product

NORETHINDRONE 0.35MG

Orange Book ANDA 091209 · GLENMARK PHARMACEUTICALS LTD · Prescription

Key facts

Proprietary name NORETHINDRONE
Active ingredients NORETHINDRONE
Strength 0.35MG
Dosage form TABLET
Route ORAL-28
Application ANDA091209
Applicant holder GLENMARK PHARMACEUTICALS LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AB2
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jul 22, 2010

At a glance

  • 10–99 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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