Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090385
Company: GLENMARK PHARMS LTD
Company: GLENMARK PHARMS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LEVOCETIRIZINE DIHYDROCHLORIDE | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 02/24/2011 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/05/2020 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/27/2018 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/27/2018 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/27/2018 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/27/2018 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/27/2018 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/25/2015 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/29/2013 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/05/2013 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
LEVOCETIRIZINE DIHYDROCHLORIDE
TABLET;ORAL; 5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LEVOCETIRIZINE DIHYDROCHLORIDE | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 090392 | DR REDDYS LABS LTD |
| LEVOCETIRIZINE DIHYDROCHLORIDE | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 090385 | GLENMARK PHARMS LTD |
| LEVOCETIRIZINE DIHYDROCHLORIDE | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 091264 | HETERO LABS LTD III |
| LEVOCETIRIZINE DIHYDROCHLORIDE | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 204626 | IPCA LABS LTD |
| LEVOCETIRIZINE DIHYDROCHLORIDE | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 205564 | MACLEODS PHARMS LTD |
| LEVOCETIRIZINE DIHYDROCHLORIDE | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 202046 | MICRO LABS LTD INDIA |
| LEVOCETIRIZINE DIHYDROCHLORIDE | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 203646 | SCIEGEN PHARMS INC |
| LEVOCETIRIZINE DIHYDROCHLORIDE | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 090362 | SUN PHARM |
| LEVOCETIRIZINE DIHYDROCHLORIDE | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 090229 | SYNTHON PHARMS |
| LEVOCETIRIZINE DIHYDROCHLORIDE | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 090199 | TEVA PHARMS |