Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076447
Company: TEVA
Company: TEVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET;ORAL | Discontinued | None | No | No |
| CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET;ORAL | Discontinued | None | No | No |
| FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET;ORAL | Discontinued | None | No | No |
| FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Discontinued | None | No | No |
| FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Discontinued | None | No | No |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Discontinued | None | No | No |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Discontinued | None | No | No |
| FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Discontinued | None | No | No |
| FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 180MG | 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 |
|---|---|---|---|---|---|---|---|
| 09/01/2005 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/076447_ORIGINAL APPROVAL_PACKAGE.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/31/2019 | SUPPL-26 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 12/20/2012 | SUPPL-20 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/13/2011 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/04/2013 | SUPPL-17 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 03/19/2009 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 12/31/2007 | SUPPL-7 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076447s007ltr.pdf |
| 01/25/2007 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 07/07/2006 | SUPPL-4 | Labeling |
Label is not available on this site. |
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY
There are no other OTC drugs with the same Active Ingredient, Strength and Dosage Form/Route.
CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES
There are no other OTC drugs with the same Active Ingredient, Strength and Dosage Form/Route.
FEXOFENADINE HYDROCHLORIDE
There are no other OTC drugs with the same Active Ingredient, Strength and Dosage Form/Route.
FEXOFENADINE HYDROCHLORIDE ALLERGY
There are no other OTC drugs with the same Active Ingredient, Strength and Dosage Form/Route.
FEXOFENADINE HYDROCHLORIDE HIVES
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET;ORAL; 180MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | Yes | 020872 | CHATTEM SANOFI |
| ALLEGRA HIVES | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | Yes | 020872 | CHATTEM SANOFI |
| FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 219032 | CONTRACT PHARMACAL |
| FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 212971 | L PERRIGO CO |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 202039 | AUROBINDO PHARMA LTD |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 076502 | DR REDDYS LABS LTD |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 211075 | GRANULES |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 204097 | HETERO LABS LTD V |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 204507 | SCIEGEN PHARMS |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 091567 | SUN PHARM INDS |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 079112 | TIME CAP LABS |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 210137 | UNIQUE |
| FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 076502 | DR REDDYS LABS LTD |
| FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 204507 | SCIEGEN PHARMS |
| FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 091567 | SUN PHARM INDS |
| FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 076447 | TEVA |
| FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 079112 | TIME CAP LABS |