Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208477
Company: AUROBINDO PHARMA LTD
Company: AUROBINDO PHARMA LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LORATADINE | LORATADINE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Over-the-counter | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 04/11/2018 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/08/2022 | SUPPL-25 |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208477s025lbl.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/08/2022 | SUPPL-25 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208477s025lbl.pdf |
LORATADINE
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; 10MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| ALAVERT | LORATADINE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Over-the-counter | No | 021375 | FDN CONSUMER |
| CLARITIN HIVES RELIEF REDITAB | LORATADINE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Over-the-counter | Yes | 020704 | BAYER HEALTHCARE LLC |
| CLARITIN REDITABS | LORATADINE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Over-the-counter | Yes | 020704 | BAYER HEALTHCARE LLC |
| LORATADINE | LORATADINE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Over-the-counter | No | 208477 | AUROBINDO PHARMA LTD |
| LORATADINE | LORATADINE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Over-the-counter | No | 076011 | PERRIGO PHARMA INTL |
| LORATADINE | LORATADINE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Over-the-counter | No | 214280 | RUBICON |
| LORATADINE | LORATADINE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Over-the-counter | No | 213294 | TENSHI |
| LORATADINE REDIDOSE | LORATADINE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Over-the-counter | No | 077153 | SUN PHARM INDS LTD |