Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018272
Company: DRAXIMAGE
Company: DRAXIMAGE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TECHNESCAN GLUCEPTATE | TECHNETIUM TC-99M GLUCEPTATE KIT | N/A | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 01/27/1982 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | 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 |
|---|---|---|---|---|---|
| 05/17/2002 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/02/1999 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 04/02/1999 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 01/27/1984 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 01/10/1983 | SUPPL-1 | Labeling |
Label is not available on this site. |