FDA Orange Book · active-ingredient family
Carbamazepine
Carbamazepine: 7 brands, 44 generics; first approved May 15, 1986; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 44 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
7
Generics (ANDA)
44
Listed patents
7
Next patent expiry
Nov 10, 2028
in 2 yr 3 mo
Brand (NDA) products
Originator applications
- CARNEXIVRLDLUNDBECK PHARMS LLCNDA 2060302016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/20ML (10MG/ML) SOLUTION INTRAVENOUS Discontinued — - EQUETRORLDVALIDUS PHARMSNDA 02171020043 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE, EXTENDED RELEASE ORAL Rx — 200MG CAPSULE, EXTENDED RELEASE ORAL Rx — 300MG CAPSULE, EXTENDED RELEASE ORAL Rx — - CARBATROLRLDTAKEDA PHARMS USANDA 02071219973 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 300MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 100MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - TEGRETOL-XRRLDNOVARTISNDA 02023419963 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, EXTENDED RELEASE ORAL Rx AB 200MG TABLET, EXTENDED RELEASE ORAL Rx AB 400MG TABLET, EXTENDED RELEASE ORAL Rx AB - NOVARTISNDA 0189271987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/5ML SUSPENSION ORAL Rx AB - TEGRETOLRLDNOVARTISNDA 018281—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, CHEWABLE ORAL Discontinued — - NOVARTISNDA 016608—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx AB
Generic (ANDA) products (44)
Abbreviated applications
- CARBAMAZEPINEALEMBICANDA 21993920253 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, EXTENDED RELEASE ORAL Rx AB 200MG TABLET, EXTENDED RELEASE ORAL Rx AB 400MG TABLET, EXTENDED RELEASE ORAL Rx AB - CARBAMAZEPINEALEMBICANDA 2166232025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx AB - CARBAMAZEPINEYICHANG HUMANWELLANDA 21907220253 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, EXTENDED RELEASE ORAL Rx AB 200MG TABLET, EXTENDED RELEASE ORAL Rx AB 400MG TABLET, EXTENDED RELEASE ORAL Rx AB - CARBAMAZEPINEALKEM LABS LTDANDA 21727720253 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, EXTENDED RELEASE ORAL Rx AB 200MG TABLET, EXTENDED RELEASE ORAL Rx AB 400MG TABLET, EXTENDED RELEASE ORAL Rx AB - CARBAMAZEPINETORRENTANDA 21252420253 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, EXTENDED RELEASE ORAL Rx AB 200MG TABLET, EXTENDED RELEASE ORAL Rx AB 400MG TABLET, EXTENDED RELEASE ORAL Rx AB - CARBAMAZEPINEOSMOTICA PHARM USANDA 21566420243 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, EXTENDED RELEASE ORAL Discontinued — 200MG TABLET, EXTENDED RELEASE ORAL Discontinued — 400MG TABLET, EXTENDED RELEASE ORAL Discontinued — - CARBAMAZEPINEAPOTEXANDA 21315920243 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, EXTENDED RELEASE ORAL Discontinued — 200MG TABLET, EXTENDED RELEASE ORAL Discontinued — 400MG TABLET, EXTENDED RELEASE ORAL Discontinued — - CARBAMAZEPINEBIONPHARMAANDA 2182212024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx AB - CARBAMAZEPINEAMNEAL PHARMSANDA 21270420233 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, EXTENDED RELEASE ORAL Discontinued — 200MG TABLET, EXTENDED RELEASE ORAL Discontinued — 400MG TABLET, EXTENDED RELEASE ORAL Discontinued — - CARBAMAZEPINEAJANTA PHARMA LTDANDA 21619320233 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, EXTENDED RELEASE ORAL Discontinued — 200MG TABLET, EXTENDED RELEASE ORAL Discontinued — 400MG TABLET, EXTENDED RELEASE ORAL Discontinued — - CARBAMAZEPINESCIECURE PHARMA INCANDA 21623520233 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, EXTENDED RELEASE ORAL Rx AB 200MG TABLET, EXTENDED RELEASE ORAL Rx AB 400MG TABLET, EXTENDED RELEASE ORAL Rx AB - CARBAMAZEPINEINGENUS PHARMS LLCANDA 21640420223 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, EXTENDED RELEASE ORAL Rx AB 200MG TABLET, EXTENDED RELEASE ORAL Rx AB 400MG TABLET, EXTENDED RELEASE ORAL Rx AB - CARBAMAZEPINENOVITIUM PHARMAANDA 2142772022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/5ML SUSPENSION ORAL Rx AB - CARBAMAZEPINEUNICHEMANDA 2132842022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx AB - CARBAMAZEPINEUMEDICAANDA 21659420223 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, EXTENDED RELEASE ORAL Rx AB 200MG TABLET, EXTENDED RELEASE ORAL Rx AB 400MG TABLET, EXTENDED RELEASE ORAL Rx AB - CARBAMAZEPINEZHEJIANG JIUZHOUANDA 21559120223 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, EXTENDED RELEASE ORAL Rx AB 200MG TABLET, EXTENDED RELEASE ORAL Rx AB 400MG TABLET, EXTENDED RELEASE ORAL Rx AB - CARBAMAZEPINEANBISON LABANDA 21294820213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, EXTENDED RELEASE ORAL Rx AB 200MG TABLET, EXTENDED RELEASE ORAL Rx AB 400MG TABLET, EXTENDED RELEASE ORAL Rx AB - CARBAMAZEPINERK PHARMAANDA 2143282021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued — - CARBAMAZEPINECSPC OUYIANDA 21331120213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, EXTENDED RELEASE ORAL Rx AB 200MG TABLET, EXTENDED RELEASE ORAL Rx AB 400MG TABLET, EXTENDED RELEASE ORAL Rx AB - CARBAMAZEPINEUNIQUE PHARMANDA 21162320203 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, EXTENDED RELEASE ORAL Rx AB 200MG TABLET, EXTENDED RELEASE ORAL Rx AB 400MG TABLET, EXTENDED RELEASE ORAL Rx AB - CARBAMAZEPINEUMEDICAANDA 20779820202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx BX 200MG TABLET ORAL Rx BX - CARBAMAZEPINEZYDUS PHARMSANDA 20557120193 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, EXTENDED RELEASE ORAL Rx AB 200MG TABLET, EXTENDED RELEASE ORAL Rx AB 400MG TABLET, EXTENDED RELEASE ORAL Rx AB - CARBAMAZEPINETAROANDA 20110620133 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 200MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 300MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - CARBAMAZEPINETEVA PHARMSANDA 07859220123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 200MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 300MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - CARBAMAZEPINEAPOTEX INCANDA 07898620113 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 200MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 300MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - CARBAMAZEPINEANI PHARMSANDA 07669720113 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 200MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 300MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - CARBAMAZEPINETAROANDA 07811520093 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, EXTENDED RELEASE ORAL Rx AB 200MG TABLET, EXTENDED RELEASE ORAL Rx AB 400MG TABLET, EXTENDED RELEASE ORAL Rx AB - CARBAMAZEPINETORRENT PHARMSANDA 07727220054 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — 200MG TABLET ORAL Rx AB 300MG TABLET ORAL Discontinued — 400MG TABLET ORAL Discontinued — - TAROANDA 0767292004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/5ML SUSPENSION ORAL Rx AB - TAROANDA 0765252003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued — - CARBAMAZEPINECHARTWELL RXANDA 0757142002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/5ML SUSPENSION ORAL Rx AB - CARBAMAZEPINEAPOTEXANDA 0759482002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx AB - CARBAMAZEPINETORRENT PHARMSANDA 0757122001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, CHEWABLE ORAL Rx AB - CARBAMAZEPINETAROANDA 0758752000
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/5ML SUSPENSION ORAL Discontinued — - CARBAMAZEPINETARO PHARM INDSANDA 07568720002 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, CHEWABLE ORAL Rx AB 200MG TABLET, CHEWABLE ORAL Rx — - CARBAMAZEPINETAROANDA 0746491996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx AB - TEVAANDA 0735241992
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, CHEWABLE ORAL Rx AB - CARBAMAZEPINEJUBILANT CADISTAANDA 0719401988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, CHEWABLE ORAL Discontinued — - CARBAMAZEPINEACTAVIS ELIZABETHANDA 0716961987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued — - CARBAMAZEPINEPLIVAANDA 0714791987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued — - CARBAMAZEPINEWARNER CHILCOTTANDA 0704291987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued — - TEVAANDA 0705411986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx AB - CARBAMAZEPINEINWOOD LABSANDA 0702311986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued — - CARBAMAZEPINEUSL PHARMAANDA 0703001986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 9629797 | in 2 yr 3 mo | U-2004 | |
| 9770407 | in 2 yr 3 mo | Product | |
| 7635773 | in 2 yr 7 mo | Product | |
| 9750822 | in 2 yr 7 mo | Product | |
| 8410077 | in 2 yr 7 mo | Product | |
| 9493582 | in 6 yr 7 mo | Product | |
| 11529357 | in 13 yr 8 mo | Product |
Approval history
FDA approval span
First approval
40 yr 10 mo ago
Most recent approval
1 yr 1 mo ago
Approvals span 1986–2025 across 51 FDA applications.
Brand (NDA) 714%
Generic (ANDA) 4486%
Carbamazepine: 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.
