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 1 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 - - AMOXICILLINCHARTWELL RXANDA 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 - - AMOXICILLINCHARTWELL RXANDA 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 - - AMOXICILLINCHARTWELL RXANDA 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 - AMOXICILLINCHARTWELL RXANDA 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 - AMOXICILLINMYLANANDA 062067-2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Discontinued - 500MG CAPSULE ORAL Discontinued - - 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 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 - 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 - - 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 1 mo | SubstanceProductU-897 | |
| 8357394 | in 1 mo | Product | |
| 8299052 | in 6 mo | U-1304 |
Approval history
FDA approval span
First approval
44 yr 7 mo ago
Most recent approval
4 yr 5 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.
Related FDA reference tools
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- 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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