Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050751
Company: DEN-MAT
Company: DEN-MAT
| 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 |
| 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 |