FDA Orange Book · active-ingredient family
Anagrelide hydrochloride
Anagrelide hydrochloride: 1 brand, 9 generics; first approved Mar 14, 1997; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 9 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
9
Listed patents
0
Presentations
20
Brand (NDA) products
Originator applications
- AGRYLINRLDTAKEDA PHARMS USANDA 02033319972 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5MG BASE CAPSULE ORAL Rx AB EQ 1MG BASE CAPSULE ORAL Discontinued —
Generic (ANDA) products (9)
Abbreviated applications
- ANAGRELIDE HYDROCHLORIDETORRENTANDA 20915120172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5MG BASE CAPSULE ORAL Rx AB EQ 1MG BASE CAPSULE ORAL Rx AB - ANAGRELIDE HYDROCHLORIDERISINGANDA 07761320062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5MG BASE CAPSULE ORAL Discontinued — EQ 1MG BASE CAPSULE ORAL Discontinued — - ANAGRELIDE HYDROCHLORIDEBARR LABSANDA 07653020052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5MG BASE CAPSULE ORAL Discontinued — EQ 1MG BASE CAPSULE ORAL Discontinued — - ANAGRELIDE HYDROCHLORIDECHARTWELL RXANDA 07668320052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5MG BASE CAPSULE ORAL Discontinued — EQ 1MG BASE CAPSULE ORAL Discontinued — - ANAGRELIDE HYDROCHLORIDECIPLAANDA 07646820052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5MG BASE CAPSULE ORAL Rx AB EQ 1MG BASE CAPSULE ORAL Rx AB - ANAGRELIDE HYDROCHLORIDEIMPAX LABSANDA 07691020052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5MG BASE CAPSULE ORAL Rx AB EQ 1MG BASE CAPSULE ORAL Rx AB - ANAGRELIDE HYDROCHLORIDENOVITIUM PHARMAANDA 07681120052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5MG BASE CAPSULE ORAL Rx AB EQ 1MG BASE CAPSULE ORAL Rx AB - ANAGRELIDE HYDROCHLORIDEROXANEANDA 07648920052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5MG BASE CAPSULE ORAL Discontinued — EQ 1MG BASE CAPSULE ORAL Discontinued — - ANAGRELIDE HYDROCHLORIDEWATSON LABSANDA 07641720052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5MG BASE CAPSULE ORAL Discontinued — EQ 1MG BASE CAPSULE 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
29 yr 10 mo ago
Most recent approval
9 yr 3 mo ago
Approvals span 1997–2017 across 10 FDA applications.
Brand (NDA) 110%
Generic (ANDA) 990%
Anagrelide 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.
