Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018118
Company: GLAXOSMITHKLINE LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LANOXICAPS DIGOXIN 0.2MG CAPSULE;ORAL Discontinued None No No
LANOXICAPS DIGOXIN 0.05MG CAPSULE;ORAL Discontinued None No No
LANOXICAPS DIGOXIN 0.1MG CAPSULE;ORAL Discontinued None No No
LANOXICAPS DIGOXIN 0.15MG 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
07/26/1982 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018118_lanoxicaps_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/28/1998 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

07/15/1998 SUPPL-16 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/9330-s020_lanoxin.pdf
06/25/1996 SUPPL-15 Labeling

Label is not available on this site.

04/28/1994 SUPPL-14 Labeling

Label is not available on this site.

05/05/1994 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/06/1993 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

05/07/1992 SUPPL-11 Labeling

Label is not available on this site.

01/31/1989 SUPPL-10 Labeling

Label is not available on this site.

05/22/1987 SUPPL-9 Labeling

Label is not available on this site.

09/04/1986 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

06/18/1984 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

08/12/1986 SUPPL-6 Labeling

Label is not available on this site.

05/10/1984 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/05/1984 SUPPL-4 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/12/1986 SUPPL-3 Labeling

Label is not available on this site.

09/24/1984 SUPPL-2 Efficacy

Label is not available on this site.

01/09/1984 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

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