Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210088
Company: SUN PHARM
Company: SUN PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LORATADINE | LORATADINE | 5MG | TABLET, CHEWABLE;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 |
|---|---|---|---|---|---|---|---|
| 04/16/2018 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210088Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/13/2023 | SUPPL-12 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 03/05/2020 | SUPPL-7 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
LORATADINE
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET, CHEWABLE;ORAL; 5MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| CHILDREN'S CLARITIN | LORATADINE | 5MG | TABLET, CHEWABLE;ORAL | Over-the-counter | Yes | 021891 | BAYER HEALTHCARE LLC |
| LORATADINE | LORATADINE | 5MG | TABLET, CHEWABLE;ORAL | Over-the-counter | No | 210033 | PERRIGO PHARMA INTL |
| LORATADINE | LORATADINE | 5MG | TABLET, CHEWABLE;ORAL | Over-the-counter | No | 210088 | SUN PHARM |