Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 090392
Company: DR REDDYS LABS LTD
Company: DR REDDYS LABS 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 | 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 |
|---|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|
| 11/29/2012 | SUPPL-2 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/21/2011 | SUPPL-1 | 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 | 203027 | APOTEX INC |
| 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 GENERICS |
| 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 | 204323 | NEOPHARMA |
| 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 | 201653 | SUN PHARM INDS LTD |
| 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 |
| XYZAL | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | Yes | AB | 022064 | SANOFI AVENTIS US |
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