FDA Approval for XYZAL ALLERGY 24HR issued to CHATTEM SANOFI
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Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 209089
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 | 5MG | TABLET;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 |
|---|---|---|---|---|---|
| 07/11/2024 | SUPPL-7 | Labeling-Container/Carton Labels |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 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.
TABLET;ORAL; 5MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| LEVOCETIRIZINE DIHYDROCHLORIDE | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 211443 | APOTEX |
| LEVOCETIRIZINE DIHYDROCHLORIDE | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 210375 | DR REDDYS |
| LEVOCETIRIZINE DIHYDROCHLORIDE | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 213513 | HETERO LABS LTD III |
| LEVOCETIRIZINE DIHYDROCHLORIDE | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 211551 | MICRO LABS |
| LEVOCETIRIZINE DIHYDROCHLORIDE | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 211983 | PERRIGO R AND D |
| XYZAL ALLERGY 24HR | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | Yes | 209089 | CHATTEM SANOFI |