Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019368
Company: ETHITEK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MOCTANIN MONOCTANOIN 100% LIQUID;PERFUSION, BILIARY 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
10/29/1985 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019368Orig1s000rev.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/03/1992 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

07/03/1991 SUPPL-10 Labeling

Label is not available on this site.

10/04/1990 SUPPL-9 Labeling

Label is not available on this site.

11/12/2002 SUPPL-8 Labeling

Label is not available on this site.

11/12/2002 SUPPL-7 Labeling

Label is not available on this site.

03/22/1990 SUPPL-6 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

11/12/2002 SUPPL-5 Labeling

Label is not available on this site.

04/21/1988 SUPPL-4 Labeling

Label is not available on this site.

02/12/1990 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

11/12/2002 SUPPL-2 Labeling

Label is not available on this site.

12/22/1986 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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