Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050751
Company: TOLMAR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ATRIDOX DOXYCYCLINE HYCLATE 50MG SYSTEM, EXTENDED RELEASE;PERIODONTAL Prescription None Yes Yes
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.

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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