FDA Drug Information on Progesterone

Regulatory Status Information for Drug Progesterone

FDA Approved Drugs (Drug Name and Active Ingredients)

  • AMEN: MEDROXYPROGESTERONE ACETATE by AMARIN PHARMS
  • CRINONE: PROGESTERONE – Vaginal Gel by ACTAVIS LABS UT INC
  • CURRETAB: MEDROXYPROGESTERONE ACETATE – Oral Tablet by SOLVAY (Discontinued)
  • CYCRIN: MEDROXYPROGESTERONE ACETATE – Oral Tablet by ESI (Discontinued)
  • DELALUTIN: HYDROXYPROGESTERONE CAPROATE – Injectable/Injection by BRISTOL MYERS SQUIBB (Discontinued)
  • DEPO-PROVERA: MEDROXYPROGESTERONE ACETATE – Injectable/Injection (150 MG/ML and 400 MG/ML) by PHARMACIA AND UPJOHN
  • DEPO-SUBQ PROVERA 104: MEDROXYPROGESTERONE ACETATE – Injectable/Subcutaneous Injection (RLD) by PHARMACIA AND UPJOHN (FDA Review History for DEPO-SUBQ PROVERA 104; Approved on December 17, 2004
  • ENDOMETRIN: PROGESTERONE – Vaginal Insert (RLD) by Ferring – Approved on June 21, 2007
  • HYDROXYPROGESTERONE CAPROATE: HYDROXYPROGESTERONE CAPROATE
    • HYDROXYPROGESTERONE CAPROATE (NDA # 017439): INJECTABLE;INJECTION Multiple Strengths Discontinued ACTAVIS LABS UT INC
    • HYDROXYPROGESTERONE CAPROATE (NDA#: 018004): INJECTABLE;INJECTION 125MG/ML Discontinued AKORN
    • HYDROXYPROGESTERONE CAPROATE(NDA#: 089330): Injection 125MG/ML Discontinued QUAD PHARMS
    • HYDROXYPROGESTERONE CAPROATE (NDA#: 089331): Injection 250MG/ML Discontinued QUAD PHARMS
    • HYDROXYPROGESTERONE CAPROATE (ANDA#: 200271): Injection 250 MG/ML Prescription by MCGUFF
  • LUNELLE: ESTRADIOL CYPIONATE; MEDROXYPROGESTERONE ACETATE – Injectable/Intramuscular (NO RLD) Discontinued by PHARMACIA AND UPJOHN
    • LUNELLE Monthly Contraceptive Injection contains  medroxyprogesterone acetate and estradiol cypionate as its active ingredients.
  • MAKENA: HYDROXYPROGESTERONE CAPROATE – Injection 1250MG/5ML (250MG/ML) – RLD by LUMARA HEALTH INC; approved on February 3, 2011
  • MEDROXYPROGESTERONE ACETATE: MEDROXYPROGESTERONE ACETATE
  • PREMPHASE (PREMARIN;CYCRIN 14/14): ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE
  • PREMPHASE 14 /14: ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE
  • PREMPRO: ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE – by WYETH PHARMS INC; approved on November 17, 1995
    • View the label approved on 08/31/2015 (PDF) for NDA no. 020527
    • PREMPRO/PREMPHASE is an estrogen  plus progestin indicated in a woman with a uterus for:
      • Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause
      • Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to Menopause
      • Prevention of Postmenopausal Osteoporosis
  • PREMPRO (PREMARIN;CYCRIN):  ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE
  • PREMPRO/PREMPHASE:  CONJUGATED ESTROGENS/MEDROXYPROGESTERONE ACETATE
  • PROGESTASERT: PROGESTERONE – INSERT, EXTENDED RELEASE;INTRAUTERINE-Discontinued by Alza
  • PROGESTERONE: PROGESTERONE
  • PROMETRIUM: PROGESTERONE
  • PROVERA:  MEDROXYPROGESTERONE ACETATE

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Learn about Actavis Pharma Progesterone Injection USP in Sesame Oil for Intramuscular Use Only

Content Updated: September 2014

Progesterone injection, a progestin, is a sterile solution of progesterone in a suitable vegetable oil available for intramuscular use.  Progesterone occurs as a white or creamy white, crystalline powder. It is odorless and is stable in air. Practically insoluble in water, it is soluble in alcohol, acetone, and dioxane and sparingly soluble in vegetable oils.

Distributed By: Actavis Pharma, Inc., Parsippany, NJ 07054 USA

Manufactured By:

Hikma Farmacêutica, Fervença 2705-906 Terrugem SNT, Portugal

FDA Guidances

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Last Updated: 2016-01-31

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