Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021952
Company: BAYER HEALTHCARE LLC
Company: BAYER HEALTHCARE LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLARITIN | LORATADINE | 10MG | CAPSULE;ORAL | Over-the-counter | None | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/09/2025 | SUPPL-24 | Manufacturing (CMC)-Facility | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021952Orig1s024lbl.pdf | |
| 05/31/2023 | SUPPL-22 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021952Orig1s022lbledt.pdf | |
| 12/21/2018 | SUPPL-18 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019658Orig1s055,021952Orig1s018Lbl.pdf | |
| 07/20/2018 | SUPPL-17 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021952Orig1s017Lbl.pdf | |
| 06/20/2018 | SUPPL-16 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021952Orig1s016lbl.pdf | |
| 06/04/2018 | SUPPL-15 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021952Orig1s015lbl.pdf | |
| 04/18/2018 | SUPPL-14 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021952Orig1s014lbl.pdf | |
| 12/09/2015 | SUPPL-12 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021952Orig1s012lbl.pdf |