AKINETON از شرکت ABBVIE

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

AKINETON از شرکت ABBVIE

New Drug Application (NDA): 012003

Company: ABBVIE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AKINETON BIPERIDEN HYDROCHLORIDE 2MG TABLET;ORAL Discontinued

None

No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/08/1959 ORIG-1 Approval

Type 1 – New Molecular Entity

STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/09/2002 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

02/04/2002 SUPPL-24 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/12003s24ltr.pdf

10/25/2000 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

12/17/1987 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

07/23/2001 SUPPL-21 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12003s18s19s20s21ltr.pdf

07/23/2001 SUPPL-20 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12003s18s19s20s21ltr.pdf

07/23/2001 SUPPL-19 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12003s18s19s20s21ltr.pdf

07/23/2001 SUPPL-18 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12003s18s19s20s21ltr.pdf

01/30/1980 SUPPL-16 Labeling

Label is not available on this site.

06/29/1976 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/14/1976 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

09/24/1975 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

05/12/1975 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

04/02/1975 SUPPL-10 Labeling

Label is not available on this site.

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