FDA Orange Book · active-ingredient family
Amoxicillin
Amoxicillin: 7 brands, 62 generics; first approved Dec 01, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 62 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
7
Generics (ANDA)
62
Listed patents
3
Next patent expiry
Dec 08, 2026
in 4 mo
Brand (NDA) products
Originator applications
- MOXATAGRLDPRAGMANDA 0508132008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 775MG TABLET, EXTENDED RELEASE ORAL Discontinued — - AMOXILRLDUS ANTIBIOTICSNDA 05076019992 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/5ML FOR SUSPENSION ORAL Discontinued — 400MG/5ML FOR SUSPENSION ORAL Rx AB - AMOXILRLDUS ANTIBIOTICSNDA 05075419982 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 875MG TABLET ORAL Discontinued — 500MG TABLET ORAL Discontinued — - AMOXILRLDGLAXOSMITHKLINENDA 050459—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Discontinued — 500MG CAPSULE ORAL Discontinued — - AMOXILRLDGLAXOSMITHKLINENDA 050460—4 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 — 50MG/ML FOR SUSPENSION ORAL Discontinued — 50MG/ML FOR SUSPENSION ORAL Discontinued — - AMOXILRLDUS ANTIBIOTICSNDA 050542—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET, CHEWABLE ORAL Discontinued — 125MG TABLET, CHEWABLE ORAL Discontinued — - US ANTIBIOTICSNDA 05076119992 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET, CHEWABLE ORAL Discontinued — 400MG TABLET, CHEWABLE ORAL Discontinued —
Generic (ANDA) products (62)
Abbreviated applications
- AMOXICILLINMICRO LABSANDA 20747120222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Rx AB 500MG CAPSULE ORAL Rx AB - AMOXICILLINHIKMAANDA 20527420202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET, CHEWABLE ORAL Discontinued — 250MG TABLET, CHEWABLE ORAL Discontinued — - AMOXICILLINAUROBINDO PHARMA LTDANDA 20403020142 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG/5ML FOR SUSPENSION ORAL Rx AB 250MG/5ML FOR SUSPENSION ORAL Rx AB - AMOXICILLINCHARTWELL RXANDA 0653442009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 875MG TABLET ORAL Discontinued — - AMOXICILLINCHARTWELL RXANDA 0653192007
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG/5ML FOR SUSPENSION ORAL Rx AB - AMOXICILLINSANDOZANDA 06538720072 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG/5ML FOR SUSPENSION ORAL Rx AB 250MG/5ML FOR SUSPENSION ORAL Rx AB - AMOXICILLINSANDOZANDA 06537820072 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/5ML FOR SUSPENSION ORAL Rx AB 400MG/5ML FOR SUSPENSION ORAL Rx AB - AMOXICILLINHIKMA PHARMSANDA 06529120072 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Rx AB 500MG CAPSULE ORAL Rx AB - AMOXICILLINAUROBINDO PHARMA LTDANDA 06532420072 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET, FOR SUSPENSION ORAL Discontinued — 400MG TABLET, FOR SUSPENSION ORAL Discontinued — - AMOXICILLINAUROBINDOANDA 06533420062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/5ML FOR SUSPENSION ORAL Rx AB 400MG/5ML FOR SUSPENSION ORAL Rx AB - AMOXICILLINHIKMAANDA 06532220062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/5ML FOR SUSPENSION ORAL Rx AB 125MG/5ML FOR SUSPENSION ORAL Rx AB - AMOXICILLINHIKMAANDA 06532520062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG/5ML FOR SUSPENSION ORAL Rx AB 200MG/5ML FOR SUSPENSION ORAL Rx AB - AMOXICILLINHIKMAANDA 0652552006
Approved strengths under this FDA application. Strength Dosage form Route Status TE 875MG TABLET ORAL Rx AB - AMOXICILLINAUROBINDOANDA 06527120052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Rx AB 500MG CAPSULE ORAL Rx AB - AMOXICILLINAUROBINDOANDA 06525620052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx AB 875MG TABLET ORAL Rx AB - AMOXICILLINSANDOZANDA 06522820052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx AB 875MG TABLET ORAL Rx AB - RANBAXY LABS LTDANDA 0651592003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET, FOR SUSPENSION ORAL Discontinued — - RANBAXY LABS LTDANDA 06508020032 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET, FOR SUSPENSION ORAL Discontinued — 200MG TABLET, FOR SUSPENSION ORAL Discontinued — - AMOXICILLINTEVAANDA 06511920022 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/5ML FOR SUSPENSION ORAL Rx AB 400MG/5ML FOR SUSPENSION ORAL Rx AB - AMOXICILLINSUN PHARM INDS LTDANDA 06511320022 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/5ML FOR SUSPENSION ORAL Discontinued — 400MG/5ML FOR SUSPENSION ORAL Discontinued — - AMOXICILLINSUN PHARM INDS LTDANDA 06506020002 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET, CHEWABLE ORAL Discontinued — 400MG TABLET, CHEWABLE ORAL Discontinued — - AMOXICILLINSUN PHARM INDS LTDANDA 06505920002 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued — 875MG TABLET ORAL Discontinued — - AMOXICILLINTEVAANDA 06505620002 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx AB 875MG TABLET ORAL Rx AB - AMOXICILLINSUN PHARM INDS LTDANDA 06502119992 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET, CHEWABLE ORAL Discontinued — 250MG TABLET, CHEWABLE ORAL Discontinued — - AMOXICILLINSUN PHARM INDS LTDANDA 06501619992 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Discontinued — 500MG CAPSULE ORAL Discontinued — - AMOXICILLINTEVAANDA 06403119962 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET, CHEWABLE ORAL Discontinued — 250MG TABLET, CHEWABLE ORAL Discontinued — - AMOXICILLINAPOTHECONANDA 06413119962 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET, CHEWABLE ORAL Discontinued — 250MG TABLET, CHEWABLE ORAL Discontinued — - AMOXICILLINCHARTWELL RXANDA 06413919962 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET, CHEWABLE ORAL Discontinued — 250MG TABLET, CHEWABLE ORAL Discontinued — - AMOXICILLINTEVAANDA 06401319952 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET, CHEWABLE ORAL Rx — 125MG TABLET, CHEWABLE ORAL Rx — - AMOXICILLINSANDOZANDA 06407619942 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Rx AB 500MG CAPSULE ORAL Rx AB - APOTHECONANDA 06309919922 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Discontinued — 500MG CAPSULE ORAL Discontinued — - AMOXICILLINTEVAANDA 0630301989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Discontinued — - AMOXICILLINTEVAANDA 0630311989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG CAPSULE ORAL Discontinued — - AMOXICILLINTEVAANDA 0630011989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/5ML FOR SUSPENSION ORAL Discontinued — - AMOXICILLINPH HEALTHANDA 06292719882 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 — - AMOXICILLINTEVAANDA 0629461988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG/5ML FOR SUSPENSION ORAL Discontinued — - APOTHECONANDA 06288519882 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 — - AMOXICILLINSTRIDES PHARMA INTLANDA 0628841988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Discontinued — - AMOXICILLINSTRIDES PHARMA INTLANDA 0628811988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG CAPSULE ORAL Discontinued — - AMOXICILLINTEVAANDA 0628531987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Discontinued — - AMOXICILLINTEVAANDA 0628541987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG CAPSULE ORAL Discontinued — - AMOXICILLINLABS ATRALANDA 06252819852 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Discontinued — 500MG CAPSULE ORAL Discontinued — - AMOXICILLINCHARTWELLANDA 062058—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Rx AB 500MG CAPSULE ORAL Rx AB - AMOXICILLINMYLANANDA 062067—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Discontinued — 500MG CAPSULE ORAL Discontinued — - AMOXICILLINTEVAANDA 061926—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Rx AB 500MG CAPSULE ORAL Rx AB - US ANTIBIOTICSANDA 062216—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Rx AB 500MG CAPSULE ORAL Rx AB - APOTHECONANDA 061885—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Discontinued — 500MG CAPSULE ORAL Discontinued — - APOTHECONANDA 062098—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Discontinued — 500MG CAPSULE ORAL Discontinued — - APOTHECONANDA 062152—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Discontinued — 500MG CAPSULE ORAL Discontinued — - PARKE DAVISANDA 062107—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Discontinued — 500MG CAPSULE ORAL Discontinued — - WYETH AYERSTANDA 062120—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Discontinued — 500MG CAPSULE ORAL Discontinued — - AMOXICILLINCHARTWELL RXANDA 062059—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 — - AMOXICILLINMYLANANDA 062090—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 — - AMOXICILLINTEVAANDA 061931—3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG/5ML FOR SUSPENSION ORAL Discontinued — 250MG/5ML FOR SUSPENSION ORAL Rx AB 50MG/ML FOR SUSPENSION ORAL Rx AB - US ANTIBIOTICSANDA 062226—5 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG/5ML FOR SUSPENSION ORAL Rx AB 250MG/5ML FOR SUSPENSION ORAL Rx AB 125MG/5ML FOR SUSPENSION ORAL Rx AB 250MG/5ML FOR SUSPENSION ORAL Rx AB 50MG/ML FOR SUSPENSION ORAL Rx AB - APOTHECONANDA 061851—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 062323—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 061886—3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML FOR SUSPENSION ORAL Discontinued — 125MG/5ML FOR SUSPENSION ORAL Discontinued — 250MG/5ML FOR SUSPENSION ORAL Discontinued — - APOTHECONANDA 062099—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 062154—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 — - PARKE DAVISANDA 062127—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 — - WYETH AYERSTANDA 062131—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 —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 8778924 | in 4 mo | SubstanceProductU-897 | |
| 8357394 | in 4 mo | Product | |
| 8299052 | in 9 mo | U-1304 |
Approval history
FDA approval span
First approval
44 yr 4 mo ago
Most recent approval
4 yr 3 mo ago
Approvals span 1982–2022 across 69 FDA applications.
Brand (NDA) 710%
Generic (ANDA) 6290%
Amoxicillin: 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.
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- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
