Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211142
Company: EUGIA PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROXYPROGESTERONE CAPROATE HYDROXYPROGESTERONE CAPROATE 1250MG/5ML (250MG/ML) SOLUTION;INTRAMUSCULAR Prescription AP2 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
05/09/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

HYDROXYPROGESTERONE CAPROATE

SOLUTION;INTRAMUSCULAR; 1250MG/5ML (250MG/ML)
TE Code = AP2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HYDROXYPROGESTERONE CAPROATE HYDROXYPROGESTERONE CAPROATE 1250MG/5ML (250MG/ML) SOLUTION;INTRAMUSCULAR Prescription No AP2 200271 ASPEN GLOBAL INC
HYDROXYPROGESTERONE CAPROATE HYDROXYPROGESTERONE CAPROATE 1250MG/5ML (250MG/ML) SOLUTION;INTRAMUSCULAR Prescription No AP2 211142 EUGIA PHARMA

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