FDA Orange Book · active-ingredient family
Doxapram hydrochloride
Doxapram hydrochloride: 1 brand, 2 generics; first approved Jan 30, 1992; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 2 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
2
Listed patents
0
Presentations
3
Brand (NDA) products
Originator applications
- HIKMANDA 014879—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML INJECTABLE INJECTION Rx AP
Generic (ANDA) products (2)
Abbreviated applications
- DOXAPRAM HYDROCHLORIDECHARTWELL INJECTABLEANDA 0762662003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML INJECTABLE INJECTION Rx AP - DOXAPRAM HYDROCHLORIDEWATSON LABSANDA 0735291992
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML INJECTABLE INJECTION 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
35 yr ago
Most recent approval
23 yr 11 mo ago
Approvals span 1992–2003 across 3 FDA applications.
Brand (NDA) 133%
Generic (ANDA) 267%
Doxapram 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.
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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.
