BUTORPHANOL TARTRATE از شرکت WEST-WARD PHARMS INT

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 از شرکت WEST-WARD PHARMS INT

Abbreviated New Drug Application (ANDA): 075046

Company: WEST-WARD PHARMS INT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUTORPHANOL TARTRATE BUTORPHANOL TARTRATE 2MG/ML INJECTABLE;INJECTION Prescription

AP

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
08/12/1998 ORIG-1 Approval

Letter (PDF)

Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75046ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75046_Stadol.pdf

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/11/2019 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

10/30/2001 SUPPL-3 Labeling

Label is not available on this site.

04/03/2001 SUPPL-2 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

10/15/1999 SUPPL-1 Labeling

Label is not available on this site.

BUTORPHANOL TARTRATE

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
بخوانید  نیزاتیدین
به بالای صفحه بردن