ADHANSIA XR از شرکت PURDUE PHARMA LP

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

ADHANSIA XR از شرکت PURDUE PHARMA LP

New Drug Application (NDA): 212038

Company: PURDUE PHARMA LP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADHANSIA XR METHYLPHENIDATE HYDROCHLORIDE 25MG CAPSULE, EXTENDED RELEASE;ORAL Prescription

None

Yes No
ADHANSIA XR METHYLPHENIDATE HYDROCHLORIDE 35MG CAPSULE, EXTENDED RELEASE;ORAL Prescription

None

Yes No
ADHANSIA XR METHYLPHENIDATE HYDROCHLORIDE 45MG CAPSULE, EXTENDED RELEASE;ORAL Prescription

None

Yes No
ADHANSIA XR METHYLPHENIDATE HYDROCHLORIDE 55MG CAPSULE, EXTENDED RELEASE;ORAL Prescription

None

Yes No
ADHANSIA XR METHYLPHENIDATE HYDROCHLORIDE 70MG CAPSULE, EXTENDED RELEASE;ORAL Prescription

None

Yes No
ADHANSIA XR METHYLPHENIDATE HYDROCHLORIDE 85MG CAPSULE, 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
02/27/2019 ORIG-1 Approval

Type 3 – New Dosage Form

STANDARD

Label (PDF)

Letter (PDF)

Review

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212038Orig1s000lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/212038Orig1s000ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212038Orig1s000TOC.cfm

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/25/2021 SUPPL-5 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212038s005lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212038Orig1s005ltr.pdf

06/28/2021 SUPPL-2 Efficacy-Labeling Change With Clinical Data

Label (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212038s002lbl.pdf

07/03/2019 SUPPL-1 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212038s001lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/212038Orig1s001ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/28/2021 SUPPL-2

Efficacy-Labeling Change With Clinical Data

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212038s002lbl.pdf
06/25/2021 SUPPL-5

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212038s005lbl.pdf
07/03/2019 SUPPL-1

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212038s001lbl.pdf
02/27/2019 ORIG-1 Approval

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212038Orig1s000lbl.pdf
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