Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019961
Company: CHAPTER 7 TRUSTEE
Company: CHAPTER 7 TRUSTEE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GANITE | GALLIUM NITRATE | 25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | No | No |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 |
|---|---|---|---|---|---|---|---|
| 01/17/1991 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/17/2003 | SUPPL-9 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19961slr009ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019961_S009_GANITE.pdf |
| 03/27/1995 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 09/28/1993 | SUPPL-3 | Labeling |
Label is not available on this site. |