BUTALBITAL, ASPIRIN AND CAFFEINE 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, ASPIRIN AND CAFFEINE از شرکت HIKMA INTL PHARMS

Abbreviated New Drug Application (ANDA): 086162

Company: HIKMA INTL PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUTALBITAL, ASPIRIN AND CAFFEINE ASPIRIN; BUTALBITAL; CAFFEINE 325MG;50MG;40MG TABLET;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
06/05/1979 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
06/24/1999 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

10/01/1998 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

07/17/1997 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

07/17/1997 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

07/17/1997 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

07/17/1997 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

07/17/1997 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

08/12/1996 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

02/29/1996 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

10/23/1996 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

06/30/1992 SUPPL-32 Labeling

Label is not available on this site.

01/31/1991 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

04/10/1989 SUPPL-29 Bioequivalence

Label is not available on this site.

05/24/1989 SUPPL-28 Labeling

Label is not available on this site.

05/24/1989 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

02/02/1989 SUPPL-26 Labeling

Label is not available on this site.

11/17/1988 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

11/17/1988 SUPPL-24 Labeling

Label is not available on this site.

11/17/1988 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

11/17/1988 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

11/17/1988 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

08/23/1988 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

08/23/1988 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

08/23/1988 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

02/16/1984 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

10/18/1982 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

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