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CANTIL از شرکت SANOFI AVENTIS US

تصویر پیدا نشد !

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

CANTIL از شرکت SANOFI AVENTIS US

New Drug Application (NDA): 010679

Company: SANOFI AVENTIS US

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CANTIL MEPENZOLATE BROMIDE 25MG TABLET;ORAL Discontinued

None

Yes No
CANTIL MEPENZOLATE BROMIDE 25MG/5ML SOLUTION;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
11/14/1956 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
05/25/2004 SUPPL-29 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/10679slr029_cantil_lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/10679slr029ltr.pdf

01/29/1999 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

01/11/1989 SUPPL-26 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/15/1985 SUPPL-25 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/09/1982 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

05/08/1991 SUPPL-23 Labeling

Label is not available on this site.

11/04/1980 SUPPL-21 Labeling

Label is not available on this site.

11/09/1982 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/20/1980 SUPPL-17 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/25/2004 SUPPL-29

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/10679slr029_cantil_lbl.pdf
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