Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 215395
Company: INVAGEN PHARMS
Company: INVAGEN PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LANREOTIDE ACETATE | LANREOTIDE ACETATE | EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML) | SOLUTION;SUBCUTANEOUS | Prescription | None | Yes | Yes |
LANREOTIDE ACETATE | LANREOTIDE ACETATE | EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML) | SOLUTION;SUBCUTANEOUS | Prescription | None | Yes | Yes |
LANREOTIDE ACETATE | LANREOTIDE ACETATE | EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML) | SOLUTION;SUBCUTANEOUS | Prescription | None | 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 |
---|---|---|---|---|---|---|---|
12/17/2021 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215395s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/215395Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/215395Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/11/2024 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215395s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/215395Orig1s008ltr.pdf | |
09/16/2024 | SUPPL-7 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215395s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/215395Orig1s007ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
09/16/2024 | SUPPL-7 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215395s007lbl.pdf | |
07/11/2024 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215395s008lbl.pdf | |
12/17/2021 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215395s000lbl.pdf |