Drugs@FDA: FDA-Approved Drugs
Company: SUN PHARM INDS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AN-SULFUR COLLOID | TECHNETIUM TC-99M SULFUR COLLOID KIT | N/A | SOLUTION;INJECTION, ORAL | Prescription | AP | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 04/17/1978 | 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 |
|---|---|---|---|---|---|
| 12/19/2019 | SUPPL-49 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017858s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/017858Orig1s049ltr.pdf | |
| 12/04/2015 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/28/2015 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/22/2015 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/13/2015 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/22/2016 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/12/2014 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/04/2013 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/14/2012 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/13/2012 | SUPPL-35 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017858Orig1s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017858Orig1s035ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/017858Orig1s035MedR.pdf | |
| 07/22/2011 | SUPPL-34 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017858Orig1s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017858s034ltr.pdf | |
| 09/13/2002 | SUPPL-24 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17858slr024ltr.pdf |
| 08/04/1998 | SUPPL-23 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/25/1995 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/22/1989 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 04/02/1986 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/02/1985 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/12/1986 | SUPPL-15 | Efficacy |
Label is not available on this site. |
||
| 04/29/1985 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/10/1984 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/16/1981 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/26/1985 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 01/11/1982 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 06/30/1982 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/27/1982 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 05/11/1980 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/19/2019 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017858s049lbl.pdf | |
| 08/13/2012 | SUPPL-35 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017858Orig1s035lbl.pdf | |
| 07/22/2011 | SUPPL-34 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017858Orig1s034lbl.pdf |
AN-SULFUR COLLOID
SOLUTION;INJECTION, ORAL; N/A
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AN-SULFUR COLLOID | TECHNETIUM TC-99M SULFUR COLLOID KIT | N/A | SOLUTION;INJECTION, ORAL | Prescription | Yes | AP | 017858 | SUN PHARM INDS INC |