Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 010744
Company: GLAXOSMITHKLINE
Company: GLAXOSMITHKLINE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DARBID | ISOPROPAMIDE IODIDE | EQ 5MG BASE | 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 |
|---|---|---|---|---|---|---|---|
| 10/09/1957 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/09/1988 | SUPPL-21 | Labeling |
Label is not available on this site. |
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| 05/15/1986 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 12/07/2007 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 03/02/1988 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 05/15/1986 | SUPPL-17 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 12/07/2007 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 12/07/2007 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 12/07/2007 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 12/07/2007 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 12/07/2007 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 12/07/2007 | SUPPL-10 | Labeling |
Label is not available on this site. |