Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211983
Company: PERRIGO R AND D
Company: PERRIGO R AND D
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LEVOCETIRIZINE DIHYDROCHLORIDE | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET;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 |
---|---|---|---|---|---|---|---|
03/28/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/31/2019 | SUPPL-3 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
10/21/2019 | SUPPL-1 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
LEVOCETIRIZINE DIHYDROCHLORIDE
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET;ORAL; 5MG
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
LEVOCETIRIZINE DIHYDROCHLORIDE | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 211443 | APOTEX |
LEVOCETIRIZINE DIHYDROCHLORIDE | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 210375 | DR REDDYS |
LEVOCETIRIZINE DIHYDROCHLORIDE | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 213513 | HETERO LABS LTD III |
LEVOCETIRIZINE DIHYDROCHLORIDE | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 211551 | MICRO LABS |
LEVOCETIRIZINE DIHYDROCHLORIDE | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 211983 | PERRIGO R AND D |
XYZAL ALLERGY 24HR | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | Yes | 209089 | CHATTEM SANOFI |