Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018118
Company: GLAXOSMITHKLINE LLC
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. |
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| 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. |
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| 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. |
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| 01/09/1984 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |