Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 215712
Company: PERRIGO PHARMA INTL
Company: PERRIGO PHARMA INTL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NASONEX 24HR ALLERGY | MOMETASONE FUROATE | 0.05MG/SPRAY | SPRAY, METERED;NASAL | Over-the-counter | 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 |
---|---|---|---|---|---|---|---|
03/17/2022 | ORIG-1 | Approval | Type 8 - Partial Rx to OTC Switch | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215712Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215712Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/215712Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/07/2024 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215712Orig1s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/215712Orig1s017ltr.pdf | |
05/24/2023 | SUPPL-15 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215712Orig1s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215712orig1s015ltr.pdf | |
03/09/2023 | SUPPL-12 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215712Orig1s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215712Orig1s012ltr.pdf | |
09/19/2022 | SUPPL-11 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215712Orig1s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215712Orig1s011ltr.pdf | |
09/20/2022 | SUPPL-8 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215712Orig1s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215712Orig1s008ltr.pdf | |
09/20/2022 | SUPPL-7 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215712Orig1s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215712Orig1s007ltr.pdf | |
07/15/2022 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215712Orig1s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215712Orig1s006ltr.pdf | |
09/16/2022 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215712Orig1s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215712Orig1s005ltr.pdf | |
07/15/2022 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215712Orig1s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215712Orig1s004ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
06/07/2024 | SUPPL-17 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215712Orig1s017lbl.pdf | |
05/24/2023 | SUPPL-15 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215712Orig1s015lbl.pdf | |
03/09/2023 | SUPPL-12 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215712Orig1s012lbl.pdf | |
09/20/2022 | SUPPL-8 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215712Orig1s008lbl.pdf | |
09/20/2022 | SUPPL-7 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215712Orig1s007lbl.pdf | |
09/19/2022 | SUPPL-11 | Tentative Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215712Orig1s011lbl.pdf | |
09/16/2022 | SUPPL-5 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215712Orig1s005lbl.pdf | |
07/15/2022 | SUPPL-6 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215712Orig1s006lbl.pdf | |
07/15/2022 | SUPPL-4 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215712Orig1s004lbl.pdf | |
03/17/2022 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215712Orig1s000lbl.pdf |
NASONEX 24HR ALLERGY
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SPRAY, METERED;NASAL; 0.05MG/SPRAY
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
MOMETASONE FUROATE | MOMETASONE FUROATE | 0.05MG/SPRAY | SPRAY, METERED;NASAL | Over-the-counter | No | 217438 | APOTEX |
NASONEX 24HR ALLERGY | MOMETASONE FUROATE | 0.05MG/SPRAY | SPRAY, METERED;NASAL | Over-the-counter | Yes | 215712 | PERRIGO PHARMA INTL |