U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 091033
Company: HIKMA FARMACEUTICA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROGESTERONE PROGESTERONE 50MG/ML INJECTABLE;INJECTION Prescription AO No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/28/2010 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/08/2020 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

PROGESTERONE

INJECTABLE;INJECTION; 50MG/ML
TE Code = AO

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PROGESTERONE PROGESTERONE 50MG/ML INJECTABLE;INJECTION Prescription Yes AO 017362 ACTAVIS LABS UT INC
PROGESTERONE PROGESTERONE 50MG/ML INJECTABLE;INJECTION Prescription No AO 210965 EUGIA PHARMA
PROGESTERONE PROGESTERONE 50MG/ML INJECTABLE;INJECTION Prescription No AO 075906 FRESENIUS KABI USA
PROGESTERONE PROGESTERONE 50MG/ML INJECTABLE;INJECTION Prescription No AO 091033 HIKMA FARMACEUTICA
PROGESTERONE PROGESTERONE 50MG/ML INJECTABLE;INJECTION Prescription No AO 215634 XIROMED
Back to Top