Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209107
Company: AUROBINDO PHARMA LTD
Company: AUROBINDO PHARMA LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Over-the-counter | None | No | No |
CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 10MG | CAPSULE;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 |
---|---|---|---|---|---|---|---|
07/20/2018 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209107Orig1s000ltr.pdf |
CETIRIZINE HYDROCHLORIDE ALLERGY
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
CAPSULE;ORAL; 10MG
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Over-the-counter | No | 209107 | AUROBINDO PHARMA LTD |
CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Over-the-counter | Yes | 022429 | BIONPHARMA |
CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Over-the-counter | No | 213105 | CATALENT |
CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Over-the-counter | No | 205291 | STRIDES PHARMA |
CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Over-the-counter | No | 209107 | AUROBINDO PHARMA LTD |
CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Over-the-counter | Yes | 022429 | BIONPHARMA |
CETIRIZINE HYDROCHLORIDE HIVES RELIEF
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
CAPSULE;ORAL; 10MG
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Over-the-counter | No | 209107 | AUROBINDO PHARMA LTD |
CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Over-the-counter | Yes | 022429 | BIONPHARMA |
CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Over-the-counter | No | 213105 | CATALENT |
CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Over-the-counter | No | 205291 | STRIDES PHARMA |
CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Over-the-counter | No | 209107 | AUROBINDO PHARMA LTD |
CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Over-the-counter | Yes | 022429 | BIONPHARMA |