Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 209661
Company: DUCHESNAY
Company: DUCHESNAY
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BONJESTA | DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE | 20MG;20MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
11/07/2016 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/209661lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/209661Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/209661Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/31/2022 | SUPPL-8 | Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209661s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209661Orig1s008ltr.pdf | |
02/23/2022 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209661Orig1s007lbl.pdf | |
06/18/2018 | SUPPL-4 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209661s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209661Orig1s004ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/31/2022 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209661s008lbl.pdf | |
10/31/2022 | SUPPL-8 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209661s008lbl.pdf | |
10/31/2022 | SUPPL-8 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209661s008lbl.pdf | |
02/23/2022 | SUPPL-7 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209661Orig1s007lbl.pdf | |
06/18/2018 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209661s004lbl.pdf | |
11/07/2016 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/209661lbl.pdf |
BONJESTA
TABLET, EXTENDED RELEASE;ORAL; 20MG;20MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BONJESTA | DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE | 20MG;20MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 209661 | DUCHESNAY |