Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075906
Company: FRESENIUS KABI USA
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
04/25/2001 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-906_Progesterone_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75906ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-906_Progesterone.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/27/2011 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

12/05/2002 SUPPL-2 Manufacturing (CMC)-Facility

Label is not available on this site.

01/24/2002 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/25/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-906_Progesterone_prntlbl.pdf

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

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