Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020314
Company: CURIUM
Company: CURIUM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OCTREOSCAN | INDIUM IN-111 PENTETREOTIDE KIT | 3mCi/ML | INJECTABLE;INJECTION | 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 |
---|---|---|---|---|---|---|---|
06/02/1994 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/22/2021 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020314S014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020314Orig1s014ltr.pdf | |
02/09/2022 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020314Orig1s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020314Orig1s012ltr.pdf | |
04/08/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/08/1994 | 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 |
---|---|---|---|---|---|
02/09/2022 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020314Orig1s012lbl.pdf | |
12/22/2021 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020314S014lbl.pdf |
OCTREOSCAN
INJECTABLE;INJECTION; 3mCi/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
INDIUM IN-111 PENTETREOTIDE KIT | INDIUM IN-111 PENTETREOTIDE KIT | 3mCi/ML | INJECTABLE;INJECTION | Prescription | No | AP | 212785 | SUN PHARM INDS INC |
OCTREOSCAN | INDIUM IN-111 PENTETREOTIDE KIT | 3mCi/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 020314 | CURIUM |