Fexofenadine hydrochloride; pseudoephedrine hydrochloride
Fexofenadine hydrochloride; pseudoephedrine hydrochloride: 2 brands, 9 generics; first approved Apr 14, 2005; generic available.
Generic available — 9 ANDA applications approved.
Brand (NDA) products
CHATTEM SANOFINDA 0207862011
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 60MG;120MG | TABLET, EXTENDED RELEASE | ORAL | OTC | — |
CHATTEM SANOFINDA 0217042011
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 180MG;240MG | TABLET, EXTENDED RELEASE | ORAL | OTC | — |
Generic (ANDA) products (9)
L PERRIGO COANDA 2167922025
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 60MG;120MG | TABLET, EXTENDED RELEASE | ORAL | OTC | — |
AUROBINDO PHARMA LTDANDA 2152322025
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 180MG;240MG | TABLET, EXTENDED RELEASE | ORAL | OTC | — |
DR REDDYSANDA 2154342022
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 60MG;120MG | TABLET, EXTENDED RELEASE | ORAL | OTC | — |
AUROBINDO PHARMAANDA 2091162017
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 60MG;120MG | TABLET, EXTENDED RELEASE | ORAL | OTC | — |
SUN PHARMANDA 0908182015
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 60MG;120MG | TABLET, EXTENDED RELEASE | ORAL | OTC | — |
DR REDDYSANDA 0766672014
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 60MG;120MG | TABLET, EXTENDED RELEASE | ORAL | OTC | — |
DR REDDYS LABS LTDANDA 0790432011
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 180MG;240MG | TABLET, EXTENDED RELEASE | ORAL | OTC | — |
IMPAX PHARMSANDA 0762982010
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 60MG;120MG | TABLET, EXTENDED RELEASE | ORAL | Discontinued | — |
BARRANDA 0762362005
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 60MG;120MG | TABLET, EXTENDED RELEASE | ORAL | Discontinued | — |
Listed patents
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
Approvals span 2005–2025 across 11 FDA applications.
Fexofenadine hydrochloride; pseudoephedrine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
