FDA Orange Book · active-ingredient family
Cephradine
Cephradine: 2 brands, 13 generics; first approved Jan 09, 1987; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 13 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
13
Listed patents
0
Presentations
28
Brand (NDA) products
Originator applications
- ERSANANDA 050548—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Discontinued — 500MG CAPSULE ORAL Discontinued — - BRISTOL MYERS SQUIBBNDA 050530—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM TABLET ORAL Discontinued —
Generic (ANDA) products (13)
Abbreviated applications
- CEPHRADINEBARRANDA 0628581988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG/5ML FOR SUSPENSION ORAL Discontinued — - CEPHRADINEBARRANDA 0628591988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/5ML FOR SUSPENSION ORAL Discontinued — - CEPHRADINEBARRANDA 0628501988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Discontinued — - CEPHRADINEBARRANDA 0628511988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG CAPSULE ORAL Discontinued — - CEPHRADINEVITARINEANDA 06281319882 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Discontinued — 500MG CAPSULE ORAL Discontinued — - CEPHRADINEIVAX SUB TEVA PHARMSANDA 06276219872 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Discontinued — 500MG CAPSULE ORAL Discontinued — - CEPHRADINETEVAANDA 06268319872 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Discontinued — 500MG CAPSULE ORAL Discontinued — - CEPHRADINETEVAANDA 06269319872 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG/5ML FOR SUSPENSION ORAL Discontinued — 250MG/5ML FOR SUSPENSION ORAL Discontinued — - GLAXOSMITHKLINEANDA 061859—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Discontinued — 500MG CAPSULE ORAL Discontinued — - APOTHECONANDA 061764—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Discontinued — 500MG CAPSULE ORAL Discontinued — - GLAXOSMITHKLINEANDA 061866—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG/5ML FOR SUSPENSION ORAL Discontinued — 250MG/5ML FOR SUSPENSION ORAL Discontinued — - APOTHECONANDA 061763—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG/5ML FOR SUSPENSION ORAL Discontinued — 250MG/5ML FOR SUSPENSION ORAL Discontinued — - APOTHECONANDA 061976—5 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/VIAL INJECTABLE INJECTION Discontinued — 500MG/VIAL INJECTABLE INJECTION Discontinued — 2GM/VIAL INJECTABLE INJECTION Discontinued — 1GM/VIAL INJECTABLE INJECTION Discontinued — 4GM/VIAL INJECTABLE INJECTION 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
40 yr 2 mo ago
Most recent approval
38 yr 9 mo ago
Approvals span 1987–1988 across 15 FDA applications.
Brand (NDA) 213%
Generic (ANDA) 1387%
Cephradine: 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.
