Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 205410
Company: PIERRE FABRE
Company: PIERRE FABRE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HEMANGEOL | PROPRANOLOL HYDROCHLORIDE | 4.28MG/ML | SOLUTION;ORAL | 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 |
---|---|---|---|---|---|---|---|
03/14/2014 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205410s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205410Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205410Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/22/2021 | SUPPL-6 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205410s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/205410Orig1s006ltr.pdf | |
04/02/2020 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205410s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205410Orig1s005ltr.pdf | |
12/18/2019 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205410s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205410Orig1s003ltr.pdf | |
05/18/2015 | 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 |
---|---|---|---|---|---|
06/22/2021 | SUPPL-6 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205410s006lbl.pdf | |
06/22/2021 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205410s006lbl.pdf | |
04/02/2020 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205410s005lbl.pdf | |
12/18/2019 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205410s003lbl.pdf | |
03/14/2014 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205410s000lbl.pdf |