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CLARITIN REDITABS از شرکت BAYER HEALTHCARE LLC
New Drug Application (NDA): 021993
Company: BAYER HEALTHCARE LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLARITIN REDITABS | LORATADINE | 5MG | TABLET, ORALLY DISINTEGRATING;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 |
|---|---|---|---|---|---|---|---|
| 12/12/2006 | ORIG-1 | Approval |
Type 5 – New Formulation or New Manufacturer |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021993s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/28/2019 | SUPPL-17 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020704Orig1s034,021993Orig1s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020704Orig1s034, 021993Orig1s017ltr.pdf |
||
| 07/23/2018 | SUPPL-16 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021993Orig1s016,020704Orig1s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021993Orig1s016,020704Orig1s033ltr.pdf |
||
| 11/25/2015 | SUPPL-13 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021993Orig1s013, 020704Orig1s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021993Orig1s013,020704Orig1s028ltr.pdf |
||
| 07/22/2014 | SUPPL-12 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020704Orig1s027, 021993Orig1s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020704Orig1s027,021993Orig1s012ltr.pdf |
||
| 10/21/2008 | SUPPL-4 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021993s004ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/28/2019 | SUPPL-17 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020704Orig1s034,021993Orig1s017lbl.pdf | |
| 07/23/2018 | SUPPL-16 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021993Orig1s016,020704Orig1s033lbl.pdf | |
| 11/25/2015 | SUPPL-13 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021993Orig1s013, 020704Orig1s028lbl.pdf | |
| 07/22/2014 | SUPPL-12 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020704Orig1s027, 021993Orig1s012lbl.pdf | |
| 12/12/2006 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021993s000lbl.pdf |
CLARITIN REDITABS
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET, ORALLY DISINTEGRATING;ORAL; 5MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| CLARITIN REDITABS | LORATADINE | 5MG | TABLET, ORALLY DISINTEGRATING;ORAL | Over-the-counter | Yes | 021993 | BAYER HEALTHCARE LLC |
| LORATADINE | LORATADINE | 5MG | TABLET, ORALLY DISINTEGRATING;ORAL | Over-the-counter | No | 212795 | TENSHI |
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