BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE از شرکت HIKMA INTL PHARMS

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

BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE از شرکت HIKMA INTL PHARMS

Abbreviated New Drug Application (ANDA): 075618

Company: HIKMA INTL PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 325MG;50MG;40MG;30MG CAPSULE;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
03/23/2001 ORIG-1 Approval

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75618ltr.pdf

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/18/2018 SUPPL-27 REMS – PROPOSAL – D-N-A

Label is not available on this site.

06/01/2017 SUPPL-25 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

06/01/2015 SUPPL-23 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

08/01/2014 SUPPL-21 Labeling-Package Insert

Label is not available on this site.

07/08/2011 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

05/08/2009 SUPPL-17 Labeling

Label is not available on this site.

11/07/2007 SUPPL-15 Labeling

Label is not available on this site.

12/29/2003 SUPPL-12 Labeling

Label is not available on this site.

01/26/2008 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/25/2002 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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