Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018124
Company: SUN PHARM INDS INC
Company: SUN PHARM INDS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CIS-MDP | TECHNETIUM TC-99M MEDRONATE 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 |
|---|---|---|---|---|---|---|---|
| 08/29/1979 | 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 |
|---|---|---|---|---|---|
| 05/17/2016 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/26/2015 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/21/2014 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/18/2013 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/19/2005 | SUPPL-13 | Manufacturing (CMC)-Control |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018124s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018124s013ltr.pdf | |
| 05/27/1997 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/28/1989 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 04/02/1986 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/27/1986 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/02/1985 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/29/1985 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/27/1984 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 03/27/1984 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 08/18/1988 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/19/2005 | SUPPL-13 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018124s013lbl.pdf |
CIS-MDP
INJECTABLE;INJECTION; N/A
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CIS-MDP | TECHNETIUM TC-99M MEDRONATE KIT | N/A | INJECTABLE;INJECTION | Prescription | No | AP | 018124 | SUN PHARM INDS INC |
| TECHNETIUM TC-99M MEDRONATE KIT | TECHNETIUM TC-99M MEDRONATE KIT | N/A | INJECTABLE;INJECTION | Prescription | No | AP | 018107 | CARDINAL HEALTH 414 |