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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050751
Company: DEN-MAT

Products on NDA 050751

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ATRIDOX	DOXYCYCLINE HYCLATE	50MG	SYSTEM, EXTENDED RELEASE;PERIODONTAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050751

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/03/1998	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/50751lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/50751ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/50751.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/23/2015	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
04/21/2014	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
02/14/2011	SUPPL-15	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050751s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050751s015ltr.pdf
05/20/2009	SUPPL-13	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050751s013ltr.pdf
06/20/2003	SUPPL-11	Manufacturing (CMC)-Control	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50751scs011_atridox_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50751scs011ltr.pdf
03/16/2003	SUPPL-9	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50751slr009_Atridox_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50751slr009ltr.pdf
02/25/2000	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
03/26/1999	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
03/11/1999	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
10/16/1998	SUPPL-2	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
10/02/1998	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 050751

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/14/2011	SUPPL-15	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050751s015lbl.pdf
06/20/2003	SUPPL-11	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50751scs011_atridox_lbl.pdf
03/16/2003	SUPPL-9	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50751slr009_Atridox_lbl.pdf
09/03/1998	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/50751lbl.pdf

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