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BRETHINE از شرکت PHARMACARE

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

BRETHINE از شرکت PHARMACARE

New Drug Application (NDA): 018571

Company: PHARMACARE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BRETHINE TERBUTALINE SULFATE 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued

None

Yes 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
11/30/1981 ORIG-1 Approval

Type 5 – New Formulation or New Manufacturer

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
04/08/2011 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

12/19/2003 SUPPL-19 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17849slr039,18571slr019ltr.pdf

01/25/2002 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

08/17/2001 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

03/21/2000 SUPPL-15 Labeling

Label is not available on this site.

12/09/1998 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

09/17/1998 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

03/12/1998 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

09/09/1997 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

12/11/1998 SUPPL-10 Labeling

Label is not available on this site.

11/19/1997 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

07/07/1997 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

02/13/1996 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

07/05/1995 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/17/1984 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

02/09/1989 SUPPL-2 Labeling

Label is not available on this site.

02/09/1989 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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