Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017538
Company: CURIUM
Company: CURIUM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TECHNESCAN PYP KIT | TECHNETIUM TC-99M PYROPHOSPHATE KIT | N/A | INJECTABLE;INJECTION | Prescription | AP | 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 |
|---|---|---|---|---|---|---|---|
| 05/28/1974 | 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 |
|---|---|---|---|---|---|
| 03/21/2017 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017538s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017538Orig1s019ltr.pdf | |
| 11/25/2013 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/26/2007 | SUPPL-15 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 04/08/1998 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/23/1998 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/1988 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 01/30/1989 | SUPPL-11 | Efficacy-New Route Of Administration |
Label is not available on this site. |
||
| 05/21/1984 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 05/07/1982 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/09/1978 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 11/09/1978 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 08/23/1977 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/27/1977 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/11/1977 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 01/13/1976 | SUPPL-2 | 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 |
|---|---|---|---|---|---|
| 03/21/2017 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017538s019lbl.pdf |
TECHNESCAN PYP KIT
INJECTABLE;INJECTION; N/A
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CIS-PYRO | TECHNETIUM TC-99M PYROPHOSPHATE KIT | N/A | INJECTABLE;INJECTION | Prescription | No | AP | 019039 | SUN PHARM INDS INC |
| TECHNESCAN PYP KIT | TECHNETIUM TC-99M PYROPHOSPHATE KIT | N/A | INJECTABLE;INJECTION | Prescription | No | AP | 017538 | CURIUM |