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BUTORPHANOL TARTRATE PRESERVATIVE FREE 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

BUTORPHANOL TARTRATE PRESERVATIVE FREE از شرکت HOSPIRA

Abbreviated New Drug Application (ANDA): 074626

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 Prescription

AP

No Yes
BUTORPHANOL TARTRATE PRESERVATIVE FREE BUTORPHANOL TARTRATE 2MG/ML INJECTABLE;INJECTION Prescription

AP

No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/23/1997 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
10/11/2019 SUPPL-30 Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-28 Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-27 Labeling-Package Insert

Label is not available on this site.

09/18/2002 SUPPL-15 Labeling

Label is not available on this site.

10/25/2002 SUPPL-14 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

05/08/2003 SUPPL-13 Labeling

Label is not available on this site.

09/07/2001 SUPPL-12 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

02/14/2001 SUPPL-11 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

03/22/2001 SUPPL-10 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

03/22/2001 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/01/2000 SUPPL-8 Manufacturing (CMC)-Facility

Label is not available on this site.

10/22/1999 SUPPL-7 Labeling

Label is not available on this site.

03/01/2000 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/01/2000 SUPPL-5 Labeling

Label is not available on this site.

03/01/2000 SUPPL-4 Manufacturing (CMC)-Facility

Label is not available on this site.

01/07/2000 SUPPL-3 Labeling

Label is not available on this site.

01/07/2000 SUPPL-2 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

11/23/1998 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

BUTORPHANOL TARTRATE PRESERVATIVE FREE

INJECTABLE;INJECTION; 1MG/ML

TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUTORPHANOL TARTRATE BUTORPHANOL TARTRATE 1MG/ML INJECTABLE;INJECTION Prescription No AP 078400 HIKMA FARMACEUTICA
BUTORPHANOL TARTRATE PRESERVATIVE FREE BUTORPHANOL TARTRATE 1MG/ML INJECTABLE;INJECTION Prescription No AP 074626 HOSPIRA
BUTORPHANOL TARTRATE PRESERVATIVE FREE BUTORPHANOL TARTRATE 1MG/ML INJECTABLE;INJECTION Prescription No AP 075045 WEST-WARD PHARMS INT

INJECTABLE;INJECTION; 2MG/ML

TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUTORPHANOL TARTRATE BUTORPHANOL TARTRATE 2MG/ML INJECTABLE;INJECTION Prescription No AP 078400 HIKMA FARMACEUTICA
BUTORPHANOL TARTRATE BUTORPHANOL TARTRATE 2MG/ML INJECTABLE;INJECTION Prescription No AP 075046 WEST-WARD PHARMS INT
BUTORPHANOL TARTRATE PRESERVATIVE FREE BUTORPHANOL TARTRATE 2MG/ML INJECTABLE;INJECTION Prescription No AP 074626 HOSPIRA
BUTORPHANOL TARTRATE PRESERVATIVE FREE BUTORPHANOL TARTRATE 2MG/ML INJECTABLE;INJECTION Prescription No AP 075045 WEST-WARD PHARMS INT

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