Drugs@FDA: FDA-Approved Drugs
Company: CHATTEM SANOFI
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | None | Yes | No |
ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | None | Yes | Yes |
ALLEGRA HIVES | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Discontinued | None | Yes | No |
ALLEGRA HIVES | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | None | Yes | Yes |
CHILDREN'S ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
CHILDREN'S ALLEGRA HIVES | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET;ORAL | Discontinued | None | Yes | 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 |
---|---|---|---|---|---|---|---|
02/25/2000 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20872lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20872ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-872_Allegra.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/01/2023 | SUPPL-47 |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020872Orig1s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020872Orig1s047ltr.pdf | ||
10/13/2021 | SUPPL-46 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020872s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020872Orig1s046ltr.pdf | |
05/10/2016 | SUPPL-38 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020872Orig1s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020872Orig1s038ltr.pdf | |
03/23/2016 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/18/2015 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/24/2015 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/02/2014 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/12/2014 | SUPPL-32 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020872Orig1s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020872Orig1s032ltr.pdf | |
04/16/2014 | SUPPL-31 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020872Orig1s031bl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020872Orig1s031ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/020872Orig1s031.pdf | |
04/16/2013 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/23/2012 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020872Orig1s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020872Orig1s029ltr.pdf | |
02/23/2012 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020872Orig1s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020872s025ltr.pdf | |
01/24/2011 | SUPPL-23 | Efficacy-Rx To OTC Switch |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020872Orig1s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020872s023ltr.pdf | |
06/25/2008 | SUPPL-18 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020872s018,021963s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021963s002, 020872s018ltr.pdf | |
10/13/2005 | SUPPL-15 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020872s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020872s015ltr.pdf | |
05/12/2003 | SUPPL-11 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20786se8-014,20872se8-011,20625se8-012_allegra_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20786se8-014,20872se8-011,20625se8-012ltr.pdf | |
10/10/2002 | SUPPL-10 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020872_s010_ALLEGRA_TABLETS.pdf |
12/10/2002 | SUPPL-9 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020872_s009_ALLEGRA_TABLETS.pdf |
02/20/2002 | SUPPL-8 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020872_s008_ALLEGRA_TABLETS.pdf |
07/11/2001 | SUPPL-7 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20625s11ltr.pdf |
01/05/2001 | SUPPL-5 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020872_s005_ALLEGRA_TABLETS.pdf |
05/30/2001 | SUPPL-4 | Manufacturing (CMC)-Control |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-872S004_Allegra_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-872S004_Allegra.pdf |
05/12/2003 | SUPPL-3 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20872se8-003,20625se8-010_allegra_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20872se8-003,20625se8-010ltr.pdf | |
03/21/2000 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-872S004_Allegra_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-872S004_Allegra.pdf |
04/14/2000 | SUPPL-1 | Manufacturing (CMC) |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-872S004_Allegra_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-872S004_Allegra.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/01/2023 | SUPPL-47 | Manufacturing (CMC) | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020872Orig1s047lbl.pdf | |
10/13/2021 | SUPPL-46 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020872s046lbl.pdf | |
05/10/2016 | SUPPL-38 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020872Orig1s038lbl.pdf | |
09/12/2014 | SUPPL-32 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020872Orig1s032lbl.pdf | |
04/16/2014 | SUPPL-31 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020872Orig1s031bl.pdf |
08/23/2012 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020872Orig1s029lbl.pdf | |
02/23/2012 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020872Orig1s025lbl.pdf | |
01/24/2011 | SUPPL-23 | Efficacy-Rx To OTC Switch | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020872Orig1s023lbl.pdf | |
06/25/2008 | SUPPL-18 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020872s018,021963s002lbl.pdf | |
10/13/2005 | SUPPL-15 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020872s015lbl.pdf | |
05/12/2003 | SUPPL-11 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20786se8-014,20872se8-011,20625se8-012_allegra_lbl.pdf | |
05/12/2003 | SUPPL-3 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20872se8-003,20625se8-010_allegra_lbl.pdf | |
02/25/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20872lbl.pdf |
ALLEGRA 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 |
ALLEGRA 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 | 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 |
CHILDREN'S ALLEGRA ALLERGY
There are no other OTC drugs with the same Active Ingredient, Strength and Dosage Form/Route.
CHILDREN'S ALLEGRA HIVES
There are no other OTC drugs with the same Active Ingredient, Strength and Dosage Form/Route.