FDA Orange Book · active-ingredient family
Caffeine citrate
Caffeine citrate: 1 brand, 13 generics; first approved Sep 21, 1999; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 13 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
13
Listed patents
0
Presentations
15
Brand (NDA) products
Originator applications
- HIKMANDA 02079319992 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION INTRAVENOUS Rx AP EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION ORAL Discontinued —
Generic (ANDA) products (13)
Abbreviated applications
- CAFFEINE CITRATEMICRO LABSANDA 2132022019
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION ORAL Rx AA - CAFFEINE CITRATEMICRO LABSANDA 2074002017
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION INTRAVENOUS Rx AP - CAFFEINE CITRATEEUGIA PHARMAANDA 2050132015
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION INTRAVENOUS Discontinued — - CAFFEINE CITRATESAGENT PHARMSANDA 0908272012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION INTRAVENOUS Rx AP - CAFFEINE CITRATESAGENT PHARMSANDA 0911022012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION ORAL Rx AA - CAFFEINE CITRATEAM REGENTANDA 0900642009
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION ORAL Discontinued — - CAFFEINE CITRATESUN PHARMANDA 0900772009
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION INTRAVENOUS Discontinued — - CAFFEINE CITRATESUN PHARMANDA 0903572009
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION ORAL Discontinued — - CAFFEINE CITRATEFRESENIUS KABI USAANDA 0780022008
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION ORAL Rx AA - CAFFEINE CITRATEFRESENIUS KABI USAANDA 0779972007
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION INTRAVENOUS Rx AP - CAFFEINE CITRATEAM REGENTANDA 0779062007
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION INTRAVENOUS Rx AP - CAFFEINE CITRATEEXELA PHARMA SCIENCEANDA 0772332006
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION INTRAVENOUS Rx AP - CAFFEINE CITRATERSEXELA PHARMAANDA 0773042006
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION ORAL Rx AA
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
27 yr 4 mo ago
Most recent approval
6 yr 9 mo ago
Approvals span 1999–2019 across 14 FDA applications.
Brand (NDA) 17%
Generic (ANDA) 1393%
Caffeine citrate: 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.
