Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 209090
Company: CHATTEM SANOFI
Company: CHATTEM SANOFI
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
XYZAL ALLERGY 24HR | LEVOCETIRIZINE DIHYDROCHLORIDE | 2.5MG/5ML | SOLUTION;ORAL | 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 |
---|---|---|---|---|---|---|---|
01/31/2017 | ORIG-1 | Approval | Type 8 - Partial Rx to OTC Switch | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209089Orig1s000,209090Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209089Orig1s000,209090Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209089Orig1s000_209090Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/28/2022 | SUPPL-4 |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209090Orig1s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209090Orig1s004ltr.pdf | ||
07/13/2022 | SUPPL-3 | Manufacturing (CMC)-Control |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209090Orig1s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209090Orig1s003ltr.pdf | |
11/10/2020 | SUPPL-2 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209090Orig1s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209090Orig1s002ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/28/2022 | SUPPL-4 | Manufacturing (CMC) | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209090Orig1s004lbl.pdf | |
07/13/2022 | SUPPL-3 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209090Orig1s003lbl.pdf |
11/10/2020 | SUPPL-2 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209090Orig1s002lbl.pdf | |
01/31/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209089Orig1s000,209090Orig1s000lbl.pdf |
XYZAL ALLERGY 24HR
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SOLUTION;ORAL; 2.5MG/5ML
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
XYZAL ALLERGY 24HR | LEVOCETIRIZINE DIHYDROCHLORIDE | 2.5MG/5ML | SOLUTION;ORAL | Over-the-counter | Yes | 209090 | CHATTEM SANOFI |