Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 210618
Company: SLAYBACK PHARMA LLC
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 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
12/28/2018 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210618Orig1s000ltr.pdf

HYDROXYPROGESTERONE CAPROATE

SOLUTION;INTRAMUSCULAR; 1250MG/5ML (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 1250MG/5ML (250MG/ML) SOLUTION;INTRAMUSCULAR Prescription No AP 210618 SLAYBACK PHARMA LLC
MAKENA HYDROXYPROGESTERONE CAPROATE 1250MG/5ML (250MG/ML) SOLUTION;INTRAMUSCULAR Prescription Yes AP 021945 AMAG PHARMA USA

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