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BENDECTIN 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

BENDECTIN از شرکت SANOFI AVENTIS US

New Drug Application (NDA): 010598

Company: SANOFI AVENTIS US

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BENDECTIN DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE 10MG;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued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
07/30/1956 ORIG-1 Approval

Type 4 – New Combination

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
12/09/1982 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/07/1982 SUPPL-13 Labeling

Label is not available on this site.

06/16/1982 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

10/22/1981 SUPPL-11 Labeling

Label is not available on this site.

10/22/1981 SUPPL-10 Labeling

Label is not available on this site.

01/09/1981 SUPPL-9 Labeling

Label is not available on this site.

11/06/1979 SUPPL-8 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/25/1979 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

11/01/1978 SUPPL-6 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/01/1978 SUPPL-5 Labeling

Label is not available on this site.

11/09/1976 SUPPL-3 Labeling

Label is not available on this site.

11/09/1976 SUPPL-2 Efficacy

Label is not available on this site.

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