Drugs@FDA: FDA-Approved Drugs

New Drug Application (NDA): 050278
Company: AVET

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACHROMYCIN V	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE;ORAL	Prescription	AB	Yes	No
ACHROMYCIN V	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE;ORAL	Prescription	AB	Yes	No

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/31/2025	SUPPL-49	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/050278s049lbl.pdf
04/27/2015	SUPPL-37	Labeling-Package Insert	Label (PDF)	Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050278s037lbl.pdf
04/27/2015	SUPPL-37	Labeling-Package Insert	Label (PDF)	Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050278s037lbl.pdf