Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090229
Company: SYNTHON PHARMS
Company: SYNTHON PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LEVOCETIRIZINE DIHYDROCHLORIDE | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
11/26/2010 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090229s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/18/2021 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
03/18/2021 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
04/07/2017 | SUPPL-16 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
06/29/2015 | SUPPL-13 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
06/29/2015 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
06/29/2015 | SUPPL-7 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
06/30/2011 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
06/27/2011 | SUPPL-3 | Labeling-Container/Carton Labels |
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 | 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 |