FDA Orange Book · active-ingredient family
Amiodarone hydrochloride
Amiodarone hydrochloride: 4 brands, 31 generics; first approved Dec 24, 1985; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 31 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
4
Generics (ANDA)
31
Listed patents
6
Next patent expiry
Mar 13, 2029
in 2 yr 7 mo
Brand (NDA) products
Originator applications
- NEXTERONERLDBAXTER HLTHCARENDA 02232520083 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued — 150MG/100ML (1.5MG/ML) INJECTABLE INJECTION Rx — 360MG/200ML (1.8MG/ML) INJECTABLE INJECTION Rx — - CORDARONERLDWYETH PHARMS INCNDA 0203771995
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued — - CORDARONERLDWYETH PHARMSNDA 0189721985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued — - AMIODARONE HYDROCHLORIDEINTL MEDICATION SYSNDA 0215942004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (31)
Abbreviated applications
- AMIODARONE HYDROCHLORIDEZHEJIANG POLY PHARMANDA 2182532024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Rx AP - AMIODARONE HYDROCHLORIDEZYDUS PHARMS USA INCANDA 07902920233 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 400MG TABLET ORAL Rx AB - AMIODARONE HYDROCHLORIDERUBICON RESEARCHANDA 07857820213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 400MG TABLET ORAL Rx AB - AMIODARONE HYDROCHLORIDEUNICHEMANDA 2134462020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx AB - AMIODARONE HYDROCHLORIDEDR REDDYS LABS SAANDA 07538920173 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 400MG TABLET ORAL Rx AB - AMIODARONE HYDROCHLORIDEEUGIA PHARMAANDA 2045502017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued — - AMIODARONE HYDROCHLORIDECHARTWELL RXANDA 07706920163 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx AB 400MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - AMIODARONE HYDROCHLORIDEAUROBINDO PHARMA LTDANDA 2047422016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx AB - AMIODARONE HYDROCHLORIDEHOSPIRAANDA 2038842013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued — - AMIODARONE HYDROCHLORIDEHOSPIRAANDA 2038852013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued — - AMIODARONE HYDROCHLORIDEACELLAANDA 0776102008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Rx AP - AMIODARONE HYDROCHLORIDEACELLAANDA 0778342008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Rx AP - AMIODARONE HYDROCHLORIDEHIKMA FARMACEUTICAANDA 0772342008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Rx AP - AMIODARONE HYDROCHLORIDEEPIC PHARMA LLCANDA 0762322006
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued — - AMIODARONE HYDROCHLORIDERSGLAND PHARMA LTDANDA 0771612005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Rx AP - UPSHER SMITH LABSANDA 07513520053 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 400MG TABLET ORAL Rx AB - AMIODARONE HYDROCHLORIDETAROANDA 07636220032 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Discontinued — 300MG TABLET ORAL Discontinued — - AMIODARONE HYDROCHLORIDEDR REDDYSANDA 0761632003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued — - AMIODARONE HYDROCHLORIDEPAR STERILE PRODUCTSANDA 0763942003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued — - AMIODARONE HYDROCHLORIDETAROANDA 07542420022 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - AMIODARONE HYDROCHLORIDEBEDFORD LABSANDA 0762992002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued — - AMIODARONE HYDROCHLORIDEHOSPIRAANDA 0759552002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued — - AMIODARONE HYDROCHLORIDEBEDFORDANDA 0760182002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued — - AMIODARONE HYDROCHLORIDEBEN VENUEANDA 0760882002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued — - AMIODARONE HYDROCHLORIDERSFRESENIUS KABI USAANDA 0757612002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Rx AP - AMIODARONE HYDROCHLORIDEHOSPIRAANDA 0761082002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued — - AMIODARONE HYDROCHLORIDERSMYLAN INSTITUTIONALANDA 0762172002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Rx AP - AMIODARONE HYDROCHLORIDETEVAANDA 0748951999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued — - AMIODARONE HYDROCHLORIDEPHARMOBEDIENTANDA 0751881999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued — - AMIODARONE HYDROCHLORIDEUPSHER SMITH LABSANDA 07531519982 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued — 400MG TABLET ORAL Discontinued — - AMIODARONE HYDROCHLORIDETEVA PHARMSANDA 0747391998
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 7635773 | in 2 yr 7 mo | Product | |
| 8410077 | in 2 yr 7 mo | Product | |
| 10117951 | in 2 yr 7 mo | Product | |
| 9200088 | in 2 yr 7 mo | Product | |
| 9750822 | in 2 yr 7 mo | Product | |
| 9493582 | in 6 yr 8 mo | Product |
Approval history
FDA approval span
First approval
41 yr 3 mo ago
Most recent approval
2 yr ago
Approvals span 1985–2024 across 35 FDA applications.
Brand (NDA) 411%
Generic (ANDA) 3189%
Amiodarone 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 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.
