Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 050582
Company: MAYNE PHARMA

Products on NDA 50582

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DORYX	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE, DELAYED RELEASE;ORAL	Discontinued	None	Yes	No
DORYX	DOXYCYCLINE HYCLATE	EQ 75MG BASE	CAPSULE, DELAYED RELEASE;ORAL	Discontinued	None	Yes	No

Labels for NDA 050582

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/31/2025	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/050582s032lbl.pdf
03/02/2020	SUPPL-31	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050582s031lbl.pdf
02/07/2018	SUPPL-30	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050582s030lbl.pdf
09/02/2015	SUPPL-29	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/2015/050582s029lbl.pdf
02/07/2008	SUPPL-27	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050582s027lbl.pdf
05/06/2005	SUPPL-24	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050582s024lbl.pdf