Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212296
Company: SLAYBACK PHARMA LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEOXYCHOLIC ACID DEOXYCHOLIC ACID 20MG/2ML (10MG/ML) SOLUTION;SUBCUTANEOUS 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
04/02/2021 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212296Orig1s000ltr.pdf

DEOXYCHOLIC ACID

SOLUTION;SUBCUTANEOUS; 20MG/2ML (10MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEOXYCHOLIC ACID DEOXYCHOLIC ACID 20MG/2ML (10MG/ML) SOLUTION;SUBCUTANEOUS Prescription No AP 212296 SLAYBACK PHARMA LLC
KYBELLA DEOXYCHOLIC ACID 20MG/2ML (10MG/ML) SOLUTION;SUBCUTANEOUS Prescription Yes AP 206333 KYTHERA BIOPHARMS

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