Orange Book product

PROGESTERONE 100MG

Orange Book ANDA 208801 · DR REDDYS LABORATORIES INC · Prescription

Key facts

Proprietary name PROGESTERONE
Active ingredients PROGESTERONE
Strength 100MG
Dosage form CAPSULE
Route ORAL
Application ANDA208801
Applicant holder DR REDDYS LABORATORIES INC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Feb 28, 2017

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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