Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208994
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 TC99M MERTIATIDE KIT | TECHNETIUM TC-99M MERTIATIDE 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 |
---|---|---|---|---|---|---|---|
07/12/2019 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208994Orig1s000ltr.pdf |
TECHNETIUM TC99M MERTIATIDE KIT
INJECTABLE;INJECTION; N/A
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TECHNESCAN MAG3 | TECHNETIUM TC-99M MERTIATIDE KIT | N/A | INJECTABLE;INJECTION | Prescription | Yes | AP | 019882 | CURIUM |
TECHNETIUM TC99M MERTIATIDE KIT | TECHNETIUM TC-99M MERTIATIDE KIT | N/A | INJECTABLE;INJECTION | Prescription | No | AP | 206489 | MEDI-RADIOPHARMA |
TECHNETIUM TC99M MERTIATIDE KIT | TECHNETIUM TC-99M MERTIATIDE KIT | N/A | INJECTABLE;INJECTION | Prescription | No | AP | 208994 | SUN PHARM INDS INC |