Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 079157
Company: SUN PHARM INDS INC
Company: SUN PHARM INDS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TECHNETIUM TC 99M SESTAMIBI | TECHNETIUM TC-99M SESTAMIBI KIT | 10-30mCi | 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 |
---|---|---|---|---|---|---|---|
07/10/2009 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/11/2023 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
TECHNETIUM TC 99M SESTAMIBI
INJECTABLE;INJECTION; 10-30mCi
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TECHNETIUM TC 99M SESTAMIBI | TECHNETIUM TC-99M SESTAMIBI KIT | 10-30mCi | INJECTABLE;INJECTION | Prescription | No | AP | 079157 | SUN PHARM INDS INC |