Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019594
Company: ALLERGAN SALES LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACTIGALL URSODIOL 150MG CAPSULE;ORAL Discontinued None No No
ACTIGALL URSODIOL 300MG CAPSULE;ORAL Prescription AB Yes 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
12/31/1987 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/27/2016 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

10/30/2015 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

08/14/2002 SUPPL-21 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19594slr021ltr.pdf
04/22/1999 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/19/1999 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

06/05/1996 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

09/15/1995 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

03/29/1996 SUPPL-16 Efficacy-New Indication

Label is not available on this site.

03/15/2002 SUPPL-13 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/24/1992 SUPPL-11 Labeling

Label is not available on this site.

10/05/1990 SUPPL-10 Labeling

Label is not available on this site.

10/04/1991 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

05/19/1989 SUPPL-8 Labeling

Label is not available on this site.

08/02/1989 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

04/19/1989 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/30/1988 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/26/1988 SUPPL-4 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/08/1988 SUPPL-3 Labeling

Label is not available on this site.

07/08/1988 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/14/1989 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

ACTIGALL

CAPSULE;ORAL; 300MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACTIGALL URSODIOL 300MG CAPSULE;ORAL Prescription Yes AB 019594 ALLERGAN SALES LLC
URSODIOL URSODIOL 300MG CAPSULE;ORAL Prescription No AB 075517 EPIC PHARMA
URSODIOL URSODIOL 300MG CAPSULE;ORAL Prescription No AB 079082 LANNETT
URSODIOL URSODIOL 300MG CAPSULE;ORAL Prescription No AB 090530 MYLAN
URSODIOL URSODIOL 300MG CAPSULE;ORAL Prescription No AB 075592 TEVA PHARMS

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