Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211777
Company: ASPEN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROXYPROGESTERONE CAPROATE HYDROXYPROGESTERONE CAPROATE 250MG/ML (250MG/ML) SOLUTION;INTRAMUSCULAR Prescription AP 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
08/08/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

HYDROXYPROGESTERONE CAPROATE

SOLUTION;INTRAMUSCULAR; 250MG/ML (250MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HYDROXYPROGESTERONE CAPROATE HYDROXYPROGESTERONE CAPROATE 250MG/ML (250MG/ML) SOLUTION;INTRAMUSCULAR Prescription No AP 210723 AM REGENT
HYDROXYPROGESTERONE CAPROATE HYDROXYPROGESTERONE CAPROATE 250MG/ML (250MG/ML) SOLUTION;INTRAMUSCULAR Prescription No AP 211777 ASPEN
HYDROXYPROGESTERONE CAPROATE HYDROXYPROGESTERONE CAPROATE 250MG/ML (250MG/ML) SOLUTION;INTRAMUSCULAR Prescription No AP 211071 EUGIA PHARMA
HYDROXYPROGESTERONE CAPROATE HYDROXYPROGESTERONE CAPROATE 250MG/ML (250MG/ML) SOLUTION;INTRAMUSCULAR Prescription No AP 210877 SLAYBACK PHARMA LLC
MAKENA PRESERVATIVE FREE HYDROXYPROGESTERONE CAPROATE 250MG/ML (250MG/ML) SOLUTION;INTRAMUSCULAR Prescription Yes AP 021945 AMAG PHARMA USA

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