ADZENYS XR-ODT از شرکت NEOS THERAPS

اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

ADZENYS XR-ODT از شرکت NEOS THERAPS

New Drug Application (NDA): 204326

Company: NEOS THERAPS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADZENYS XR-ODT AMPHETAMINE EQ 3.1MG BASE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL Prescription

None

Yes No
ADZENYS XR-ODT AMPHETAMINE EQ 6.3MG BASE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL Prescription

None

Yes No
ADZENYS XR-ODT AMPHETAMINE EQ 9.4MG BASE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL Prescription

None

Yes No
ADZENYS XR-ODT AMPHETAMINE EQ 12.5MG BASE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL Prescription

None

Yes No
ADZENYS XR-ODT AMPHETAMINE EQ 15.7MG BASE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL Prescription

None

Yes No
ADZENYS XR-ODT AMPHETAMINE EQ 18.8MG BASE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL 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
01/27/2016 ORIG-1 Approval

Type 5 – New Formulation or New Manufacturer

STANDARD

Label (PDF)

Letter (PDF)

Review

https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204326s000lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204326Orig1s000ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/204326Orig1_toc.cfm

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/04/2017 SUPPL-2 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204326s002lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204326Orig1s002ltr.pdf

11/18/2016 SUPPL-1 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204326s001lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204326Orig1s001ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/04/2017 SUPPL-2

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204326s002lbl.pdf
11/18/2016 SUPPL-1

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204326s001lbl.pdf
01/27/2016 ORIG-1 Approval

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204326s000lbl.pdf
حتما بخوانید : CEPHALEXIN از شرکت APOTHECON
بخوانید  BROVANA از شرکت SUNOVION
به بالای صفحه بردن