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BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE از شرکت SANDOZ

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

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE از شرکت SANDOZ

Abbreviated New Drug Application (ANDA): 075527

Company: SANDOZ

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 2.5MG;6.25MG TABLET;ORAL Discontinued

None

No No
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 10MG;6.25MG TABLET;ORAL Discontinued

None

No No
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 5MG;6.25MG 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
09/25/2000 ORIG-1 Approval

Letter (PDF)

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75527ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75527ta.pdf

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/21/2004 SUPPL-10 Labeling

Label is not available on this site.

07/25/2002 SUPPL-6 Manufacturing (CMC)-Facility

Label is not available on this site.

07/25/2002 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/22/2002 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

01/22/2002 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/22/2002 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

01/22/2002 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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