FDA Orange Book · active-ingredient family
Galantamine hydrobromide
Galantamine hydrobromide: 3 brands, 19 generics; first approved Feb 28, 2001; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 19 ANDA applications approved.
Brands (NDA)
3
Generics (ANDA)
19
Listed patents
0
Presentations
62
Brand (NDA) products
Originator applications
- RAZADYNE ERRLDJANSSEN PHARMSNDA 02161520053 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 8MG BASE CAPSULE, EXTENDED RELEASE ORAL Discontinued - EQ 16MG BASE CAPSULE, EXTENDED RELEASE ORAL Discontinued - EQ 24MG BASE CAPSULE, EXTENDED RELEASE ORAL Discontinued - - RAZADYNERLDJANSSEN PHARMSNDA 02116920013 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE TABLET ORAL Discontinued - EQ 8MG BASE TABLET ORAL Discontinued - EQ 12MG BASE TABLET ORAL Discontinued - - JANSSEN PHARMSNDA 0212242001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG/ML SOLUTION ORAL Discontinued -
Generic (ANDA) products (19)
Abbreviated applications
- GALANTAMINE HYDROBROMIDERSAUROBINDO PHARMAANDA 20489520163 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 8MG BASE CAPSULE, EXTENDED RELEASE ORAL Rx AB EQ 16MG BASE CAPSULE, EXTENDED RELEASE ORAL Rx AB EQ 24MG BASE CAPSULE, EXTENDED RELEASE ORAL Rx AB - GALANTAMINE HYDROBROMIDEAPOTEX INCANDA 07778120113 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE TABLET ORAL Discontinued - EQ 8MG BASE TABLET ORAL Discontinued - EQ 12MG BASE TABLET ORAL Discontinued - - GALANTAMINE HYDROBROMIDEAUROBINDO PHARMA LTDANDA 09095720113 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE TABLET ORAL Rx AB EQ 8MG BASE TABLET ORAL Rx AB EQ 12MG BASE TABLET ORAL Rx AB - GALANTAMINE HYDROBROMIDEZYDUS PHARMS USA INCANDA 07889820113 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE TABLET ORAL Rx AB EQ 8MG BASE TABLET ORAL Rx AB EQ 12MG BASE TABLET ORAL Rx AB - GALANTAMINE HYDROBROMIDESUN PHARMANDA 09017820113 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 8MG BASE CAPSULE, EXTENDED RELEASE ORAL Rx AB EQ 16MG BASE CAPSULE, EXTENDED RELEASE ORAL Rx AB EQ 24MG BASE CAPSULE, EXTENDED RELEASE ORAL Rx AB - GALANTAMINE HYDROBROMIDEPHARMOBEDIENTANDA 09090020113 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 8MG BASE CAPSULE, EXTENDED RELEASE ORAL Discontinued - EQ 16MG BASE CAPSULE, EXTENDED RELEASE ORAL Discontinued - EQ 24MG BASE CAPSULE, EXTENDED RELEASE ORAL Discontinued - - GALANTAMINE HYDROBROMIDEHERITAGE PHARMAANDA 07758520093 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE TABLET ORAL Discontinued - EQ 8MG BASE TABLET ORAL Discontinued - EQ 12MG BASE TABLET ORAL Discontinued - - GALANTAMINE HYDROBROMIDECHARTWELL RXANDA 07758720093 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE TABLET ORAL Discontinued - EQ 8MG BASE TABLET ORAL Discontinued - EQ 12MG BASE TABLET ORAL Discontinued - - GALANTAMINE HYDROBROMIDESANDOZANDA 07758920093 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE TABLET ORAL Rx AB EQ 8MG BASE TABLET ORAL Rx AB EQ 12MG BASE TABLET ORAL Rx AB - GALANTAMINE HYDROBROMIDEMYLANANDA 07759020093 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE TABLET ORAL Discontinued - EQ 8MG BASE TABLET ORAL Discontinued - EQ 12MG BASE TABLET ORAL Discontinued - - GALANTAMINE HYDROBROMIDEIMPAX LABSANDA 07848420093 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 8MG BASE CAPSULE, EXTENDED RELEASE ORAL Discontinued - EQ 16MG BASE CAPSULE, EXTENDED RELEASE ORAL Discontinued - EQ 24MG BASE CAPSULE, EXTENDED RELEASE ORAL Discontinued - - GALANTAMINE HYDROBROMIDEHIKMAANDA 07760820093 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE TABLET ORAL Discontinued - EQ 8MG BASE TABLET ORAL Discontinued - EQ 12MG BASE TABLET ORAL Discontinued - - GALANTAMINE HYDROBROMIDERSYABAO PHARMANDA 07760420093 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE TABLET ORAL Rx AB EQ 8MG BASE TABLET ORAL Rx AB EQ 12MG BASE TABLET ORAL Rx AB - GALANTAMINE HYDROBROMIDERSHIKMAANDA 0781852009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG/ML SOLUTION ORAL Rx - - GALANTAMINE HYDROBROMIDEWATSON LABSANDA 07902820083 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 8MG BASE CAPSULE, EXTENDED RELEASE ORAL Rx AB EQ 16MG BASE CAPSULE, EXTENDED RELEASE ORAL Rx AB EQ 24MG BASE CAPSULE, EXTENDED RELEASE ORAL Rx AB - GALANTAMINE HYDROBROMIDEBARRANDA 07818920083 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 8MG BASE CAPSULE, EXTENDED RELEASE ORAL Rx AB EQ 16MG BASE CAPSULE, EXTENDED RELEASE ORAL Rx AB EQ 24MG BASE CAPSULE, EXTENDED RELEASE ORAL Rx AB - GALANTAMINE HYDROBROMIDESENORES PHARMSANDA 07759320083 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE TABLET ORAL Rx AB EQ 8MG BASE TABLET ORAL Rx AB EQ 12MG BASE TABLET ORAL Rx AB - GALANTAMINE HYDROBROMIDEBARRANDA 07760520083 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE TABLET ORAL Rx AB EQ 8MG BASE TABLET ORAL Rx AB EQ 12MG BASE TABLET ORAL Rx AB - GALANTAMINE HYDROBROMIDEPHARMOBEDIENTANDA 07760320083 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE TABLET ORAL Discontinued - EQ 8MG BASE TABLET ORAL Discontinued - EQ 12MG BASE TABLET ORAL 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
26 yr ago
Most recent approval
10 yr 4 mo ago
Approvals span 2001–2016 across 22 FDA applications.
Brand (NDA) 314%
Generic (ANDA) 1986%
Galantamine hydrobromide: 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.
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