Drugs@FDA: FDA-Approved Drugs
Company: SUN PHARM INDS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HEPATOLITE | TECHNETIUM TC-99M DISOFENIN 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 |
---|---|---|---|---|---|---|---|
03/16/1982 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/30/2015 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/25/2013 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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05/16/2002 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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03/15/2000 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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02/07/2000 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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11/05/1997 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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12/29/1993 | SUPPL-14 | Efficacy-New Indication |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018467-S13&S14_Hepatolite_toc.cfm |
12/29/1993 | SUPPL-13 | Labeling |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018467-S13&S14_Hepatolite_toc.cfm |
05/02/1989 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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05/19/1989 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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05/19/1989 | SUPPL-10 | Labeling |
Label is not available on this site. |
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05/19/1989 | SUPPL-9 | Efficacy-New Indication |
Label is not available on this site. |
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05/19/1989 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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02/28/1986 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/21/1983 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/07/1983 | SUPPL-2 | Labeling |
Label is not available on this site. |
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04/26/1983 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |