BUTORPHANOL TARTRATE PRESERVATIVE FREE از شرکت HOSPIRA

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

BUTORPHANOL TARTRATE PRESERVATIVE FREE از شرکت HOSPIRA

Abbreviated New Drug Application (ANDA): 075170

Company: HOSPIRA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUTORPHANOL TARTRATE PRESERVATIVE FREE BUTORPHANOL TARTRATE 1MG/ML INJECTABLE;INJECTION Discontinued

None

No No
BUTORPHANOL TARTRATE PRESERVATIVE FREE BUTORPHANOL TARTRATE 2MG/ML INJECTABLE;INJECTION 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
09/28/1998 ORIG-1 Approval

Letter (PDF)

Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75170ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75170_Butorphanol%20Tartrate.pdf

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/20/2002 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

05/03/2002 SUPPL-8 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

05/03/2002 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

06/28/2001 SUPPL-6 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

06/13/2001 SUPPL-4 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

12/01/1999 SUPPL-3 Labeling

Label is not available on this site.

08/18/2000 SUPPL-2 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

07/22/1999 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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