Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077081
Company: RISING
Company: RISING
| 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 | 180MG | TABLET;ORAL | Prescription | AB | No | No |
| FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET;ORAL | Discontinued | None | No | No |
| FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Prescription | AB | No | No |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | None | No | No |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | None | No | No |
| FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | 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 |
|---|---|---|---|---|---|---|---|
| 04/16/2007 | 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 |
|---|---|---|---|---|---|
| 10/31/2019 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/21/2011 | SUPPL-12 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 05/15/2010 | SUPPL-10 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/11/2008 | SUPPL-4 | Labeling |
Label is not available on this site. |
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY
There are no Therapeutic Equivalents.
CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES
There are no Therapeutic Equivalents.
FEXOFENADINE HYDROCHLORIDE
TABLET;ORAL; 180MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Prescription | No | AB | 076502 | DR REDDYS LABS LTD |
| FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Prescription | No | AB | 077081 | RISING |
| FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Prescription | No | AB | 076447 | TEVA |
TABLET;ORAL; 60MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Prescription | No | AB | 076502 | DR REDDYS LABS LTD |
| FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Prescription | No | AB | 077081 | RISING |
| FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Prescription | No | AB | 076447 | TEVA |
FEXOFENADINE HYDROCHLORIDE ALLERGY
There are no Therapeutic Equivalents.
FEXOFENADINE HYDROCHLORIDE HIVES
There are no Therapeutic Equivalents.
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
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET;ORAL; 60MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | Yes | 020872 | CHATTEM SANOFI |
| FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 212971 | L PERRIGO CO |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 202039 | AUROBINDO PHARMA LTD |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 076502 | DR REDDYS LABS LTD |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 211075 | GRANULES |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 204097 | HETERO LABS LTD V |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 077081 | RISING |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 204507 | SCIEGEN PHARMS INC |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 076447 | TEVA |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 079112 | WOCKHARDT |
| FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 076502 | DR REDDYS LABS LTD |
| FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 077081 | RISING |
| FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 204507 | SCIEGEN PHARMS INC |
| FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 076447 | TEVA |
| FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 079112 | WOCKHARDT |
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 | 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 | 077081 | RISING |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 204507 | SCIEGEN PHARMS INC |
| 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 | 076447 | TEVA |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 210137 | UNIQUE |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 079112 | WOCKHARDT |
| 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 | 077081 | RISING |
| FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 204507 | SCIEGEN PHARMS INC |
| 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 | WOCKHARDT |
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; 60MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | Yes | 020872 | CHATTEM SANOFI |
| FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 212971 | L PERRIGO CO |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 202039 | AUROBINDO PHARMA LTD |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 076502 | DR REDDYS LABS LTD |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 211075 | GRANULES |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 204097 | HETERO LABS LTD V |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 077081 | RISING |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 204507 | SCIEGEN PHARMS INC |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 076447 | TEVA |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 079112 | WOCKHARDT |
| FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 076502 | DR REDDYS LABS LTD |
| FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 077081 | RISING |
| FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 204507 | SCIEGEN PHARMS INC |
| FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 076447 | TEVA |
| FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 079112 | WOCKHARDT |
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 | 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 | 077081 | RISING |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 204507 | SCIEGEN PHARMS INC |
| 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 | 076447 | TEVA |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 210137 | UNIQUE |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 079112 | WOCKHARDT |
| 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 | 077081 | RISING |
| FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 204507 | SCIEGEN PHARMS INC |
| 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 | WOCKHARDT |