Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091263
Company: PADAGIS US
Company: PADAGIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LEVOCETIRIZINE DIHYDROCHLORIDE | LEVOCETIRIZINE DIHYDROCHLORIDE | 2.5MG/5ML | SOLUTION;ORAL | Prescription | AA | No | 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 |
|---|---|---|---|---|---|---|---|
| 11/07/2011 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091263s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/10/2020 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/10/2020 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/10/2020 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/10/2020 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/10/2020 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/10/2020 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/15/2015 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/27/2014 | SUPPL-2 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
LEVOCETIRIZINE DIHYDROCHLORIDE
SOLUTION;ORAL; 2.5MG/5ML
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LEVOCETIRIZINE DIHYDROCHLORIDE | LEVOCETIRIZINE DIHYDROCHLORIDE | 2.5MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 204599 | CHARTWELL MOLECULAR |
| LEVOCETIRIZINE DIHYDROCHLORIDE | LEVOCETIRIZINE DIHYDROCHLORIDE | 2.5MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 091263 | PADAGIS US |
| LEVOCETIRIZINE DIHYDROCHLORIDE | LEVOCETIRIZINE DIHYDROCHLORIDE | 2.5MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 202673 | TARO |
| LEVOCETIRIZINE HYDROCHLORIDE | LEVOCETIRIZINE DIHYDROCHLORIDE | 2.5MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 210914 | HETERO LABS LTD III |