BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE از شرکت WATSON LABS

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, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE از شرکت WATSON LABS

Abbreviated New Drug Application (ANDA): 074359

Company: WATSON LABS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE ASPIRIN; 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
08/31/1995 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
09/18/2018 SUPPL-14 REMS – PROPOSAL – D-N-A

Label is not available on this site.

08/29/2002 SUPPL-6 Labeling

Label is not available on this site.

07/31/2002 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

09/05/2001 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

10/29/1998 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

11/27/1996 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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