Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 205029
Company: BPI LABS
Company: BPI LABS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
EPINEPHRINE | EPINEPHRINE | 1MG/ML (1MG/ML) | SOLUTION;INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS | Prescription | None | Yes | Yes |
EPINEPHRINE | EPINEPHRINE | 10MG/10ML (1MG/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | Prescription | None | Yes | Yes |
EPINEPHRINE | EPINEPHRINE | 1MG/ML (1MG/ML) | SOLUTION;INTRAVENOUS | Discontinued | None | Yes | No |
EPINEPHRINE | EPINEPHRINE | 30MG/30ML (1MG/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | Prescription | None | Yes | Yes |
EPINEPHRINE | EPINEPHRINE | 1MG/ML (1MG/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, 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 |
---|---|---|---|---|---|---|---|
07/29/2014 | ORIG-1 | Approval | Type 7 - Drug Already Marketed without Approved NDA | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205029s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205029Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205029Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/28/2023 | SUPPL-13 | Manufacturing (CMC)-New Strength |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205029Orig1s013Correctedlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/205029Orig1s013Correctedltr.pdf | |
03/04/2024 | SUPPL-12 |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205029Orig1s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/205029Orig1s012ltr.pdf | ||
05/12/2023 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205029s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/205029Orig1s010ltr.pdf | |
02/04/2022 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205029Orig1s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/205029Orig1s009ltr.pdf | |
06/23/2021 | SUPPL-8 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205029Orig1s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/205029Orig1s008ltr.pdf | |
09/10/2021 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205029s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/205029Orig1s006ltr.pdf | |
05/18/2016 | SUPPL-4 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205029s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205029Orig1s004ltr.pdf | |
12/03/2015 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/11/2016 | SUPPL-2 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205029s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205029Orig1s002ltr.pdf | |
10/23/2015 | SUPPL-1 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205029s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205029Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/04/2024 | SUPPL-12 | Manufacturing (CMC) | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205029Orig1s012lbl.pdf | |
12/28/2023 | SUPPL-13 | Manufacturing (CMC)-New Strength | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205029Orig1s013Correctedlbl.pdf | |
05/12/2023 | SUPPL-10 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205029s010lbl.pdf | |
02/04/2022 | SUPPL-9 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205029Orig1s009lbl.pdf | |
09/10/2021 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205029s006lbl.pdf | |
06/23/2021 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205029Orig1s008lbl.pdf | |
06/23/2021 | SUPPL-8 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205029Orig1s008lbl.pdf | |
05/18/2016 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205029s004lbl.pdf | |
02/11/2016 | SUPPL-2 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205029s002lbl.pdf | |
10/23/2015 | SUPPL-1 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205029s001lbl.pdf | |
07/29/2014 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205029s000lbl.pdf |