Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050444
Company: REMPEX

Products on NDA 50444

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MINOCIN	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes

Labels for NDA 050444

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/31/2025	SUPPL-53	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/050444s053lbl.pdf