Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 210965
Company: EUGIA PHARMA
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
12/06/2018 ORIG-1 Approval STANDARD

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

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