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ACETYLCYSTEINE از شرکت HOSPIRA

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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

ACETYLCYSTEINE از شرکت HOSPIRA

Abbreviated New Drug Application (ANDA): 071365

Company: HOSPIRA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACETYLCYSTEINE ACETYLCYSTEINE 20% SOLUTION;INHALATION, 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
11/20/2007 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/06/2007 SUPPL-12 Labeling

Label is not available on this site.

01/18/2002 SUPPL-9 Labeling

Label is not available on this site.

01/18/2002 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/17/2001 SUPPL-7 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

05/04/2001 SUPPL-6 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

06/10/1998 SUPPL-5 Labeling

Label is not available on this site.

11/18/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/13/1998 SUPPL-3 Labeling

Label is not available on this site.

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