Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212296
Company: SLAYBACK PHARMA LLC

Products on ANDA 212296

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212296

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

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/29/2023	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 212296

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	ABBVIE