Orange Book product

PROGESTERONE 50MG/ML

Orange Book ANDA 075906 · FRESENIUS KABI USA LLC · Prescription

Key facts

Proprietary name PROGESTERONE
Active ingredients PROGESTERONE
Strength 50MG/ML
Dosage form INJECTABLE
Route INJECTION
Application ANDA075906
Applicant holder FRESENIUS KABI USA LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AO
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Apr 25, 2001

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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