FDA Orange Book · active-ingredient family
Felodipine
Felodipine: 1 brand, 13 generics; first approved Jul 25, 1991; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 13 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
13
Listed patents
0
Presentations
42
Brand (NDA) products
Originator applications
- PLENDILRLDASTRAZENECANDA 01983419943 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET, EXTENDED RELEASE ORAL Discontinued - 10MG TABLET, EXTENDED RELEASE ORAL Discontinued - 2.5MG TABLET, EXTENDED RELEASE ORAL Discontinued -
Generic (ANDA) products (13)
Abbreviated applications
- FELODIPINEYUNG SHIN PHARMANDA 20480020193 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET, EXTENDED RELEASE ORAL Rx AB 5MG TABLET, EXTENDED RELEASE ORAL Rx AB 10MG TABLET, EXTENDED RELEASE ORAL Rx AB - FELODIPINEYILINGANDA 21084720183 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET, EXTENDED RELEASE ORAL Rx AB 5MG TABLET, EXTENDED RELEASE ORAL Rx AB 10MG TABLET, EXTENDED RELEASE ORAL Rx AB - FELODIPINEJUBILANT GENERICSANDA 20398320163 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET, EXTENDED RELEASE ORAL Discontinued - 5MG TABLET, EXTENDED RELEASE ORAL Discontinued - 10MG TABLET, EXTENDED RELEASE ORAL Discontinued - - FELODIPINEORBION PHARMSANDA 20303220153 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET, EXTENDED RELEASE ORAL Rx AB 5MG TABLET, EXTENDED RELEASE ORAL Rx AB 10MG TABLET, EXTENDED RELEASE ORAL Rx AB - FELODIPINESUN PHARM INDS LTDANDA 09120020133 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET, EXTENDED RELEASE ORAL Rx AB 5MG TABLET, EXTENDED RELEASE ORAL Rx AB 10MG TABLET, EXTENDED RELEASE ORAL Rx AB - FELODIPINEHERITAGEANDA 20196420133 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET, EXTENDED RELEASE ORAL Rx AB 5MG TABLET, EXTENDED RELEASE ORAL Rx AB 10MG TABLET, EXTENDED RELEASE ORAL Rx AB - FELODIPINEAUROBINDO PHARMA LTDANDA 20341720133 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET, EXTENDED RELEASE ORAL Rx AB 5MG TABLET, EXTENDED RELEASE ORAL Rx AB 10MG TABLET, EXTENDED RELEASE ORAL Rx AB - FELODIPINEWOCKHARDT BIO AGANDA 09148420123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET, EXTENDED RELEASE ORAL Discontinued - 5MG TABLET, EXTENDED RELEASE ORAL Discontinued - 10MG TABLET, EXTENDED RELEASE ORAL Discontinued - - FELODIPINETORRENT PHARMS LTDANDA 20217020113 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET, EXTENDED RELEASE ORAL Rx AB 5MG TABLET, EXTENDED RELEASE ORAL Rx AB 10MG TABLET, EXTENDED RELEASE ORAL Rx AB - FELODIPINEPH HEALTHANDA 20081520113 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET, EXTENDED RELEASE ORAL Rx AB 5MG TABLET, EXTENDED RELEASE ORAL Rx AB 10MG TABLET, EXTENDED RELEASE ORAL Rx AB - FELODIPINEGLENMARK PHARMS LTDANDA 09036520103 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET, EXTENDED RELEASE ORAL Rx AB 5MG TABLET, EXTENDED RELEASE ORAL Rx AB 10MG TABLET, EXTENDED RELEASE ORAL Rx AB - FELODIPINEMYLANANDA 07885520083 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET, EXTENDED RELEASE ORAL Discontinued - 5MG TABLET, EXTENDED RELEASE ORAL Discontinued - 10MG TABLET, EXTENDED RELEASE ORAL Discontinued - - FELODIPINESUN PHARM INDUSTRIESANDA 07589620043 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET, EXTENDED RELEASE ORAL Discontinued - 5MG TABLET, EXTENDED RELEASE ORAL Discontinued - 10MG TABLET, EXTENDED RELEASE ORAL Discontinued -
Listed patents
Orange Book patent file
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
FDA approval span
First approval
35 yr 9 mo ago
Most recent approval
7 yr 7 mo ago
Approvals span 1991–2019 across 14 FDA applications.
Brand (NDA) 17%
Generic (ANDA) 1393%
Felodipine: 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 BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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