FDA Orange Book · active-ingredient family
Chlorpheniramine maleate
Chlorpheniramine maleate: 6 brands, 34 generics; first approved Feb 10, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 34 ANDA applications approved.
Brands (NDA)
6
Generics (ANDA)
34
Listed patents
0
Presentations
43
Brand (NDA) products
Originator applications
- BAYER HEALTHCARE LLCNDA 007638—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 8MG TABLET, EXTENDED RELEASE ORAL Discontinued — 12MG TABLET, EXTENDED RELEASE ORAL Discontinued — - ALZANDA 0197461994
Approved strengths under this FDA application. Strength Dosage form Route Status TE 16MG TABLET, EXTENDED RELEASE ORAL Discontinued — - GLAXOSMITHKLINENDA 017369—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 8MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 12MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - SCHERING PLOUGHNDA 008826—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued — - SCHERING PLOUGHNDA 008794—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML INJECTABLE INJECTION Discontinued — - SCHERINGNDA 006921—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — 2MG/5ML SYRUP ORAL Discontinued —
Generic (ANDA) products (34)
Abbreviated applications
- CHLORPHENIRAMINE MALEATERSAVANTHI INCANDA 0408292009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12MG TABLET, EXTENDED RELEASE ORAL OTC — - CHLORPHENIRAMINE MALEATEAUROLIFE PHARMA LLCANDA 0707971988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - CHLORPHENIRAMINE MALEATEPIONEER PHARMSANDA 0885561984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — - CHLORPHENIRAMINE MALEATEPHARM ASSOCANDA 0875201982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/5ML SYRUP ORAL Discontinued — - CHLORPHENIRAMINE MALEATEBEL MARANDA 080821—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued — - CHLORPHENIRAMINE MALEATEELKINS SINNANDA 080797—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued — - CHLORPHENIRAMINE MALEATEWATSON LABSANDA 083593—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued — - CHLORPHENIRAMINE MALEATEWATSON LABSANDA 086096—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued — - CHLORPHENIRAMINE MALEATEWATSON LABSANDA 086095—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML INJECTABLE INJECTION Discontinued — - BEL MARANDA 083733—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML INJECTABLE INJECTION Discontinued — - BAYER PHARMSANDA 083381—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — - CHLORPHENIRAMINE MALEATEANABOLICANDA 083078—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — - CHLORPHENIRAMINE MALEATEAUROLIFE PHARMA LLCANDA 080961—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — - CHLORPHENIRAMINE MALEATEBELL PHARMAANDA 083062—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — - CHLORPHENIRAMINE MALEATEELKINS SINNANDA 080938—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — - CHLORPHENIRAMINE MALEATEIMPAX LABSANDA 080809—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — - CHLORPHENIRAMINE MALEATEIVAX SUB TEVA PHARMSANDA 080779—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — - CHLORPHENIRAMINE MALEATEKV PHARMANDA 087164—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — - CHLORPHENIRAMINE MALEATELEDERLEANDA 086941—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — - CHLORPHENIRAMINE MALEATENEWTRON PHARMSANDA 086519—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — - CHLORPHENIRAMINE MALEATEPANRAYANDA 083243—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — - CHLORPHENIRAMINE MALEATEPHARMAVITEANDA 085104—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — - CHLORPHENIRAMINE MALEATEPHARMERALANDA 083753—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — - CHLORPHENIRAMINE MALEATEPUREPAC PHARMANDA 086306—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — - CHLORPHENIRAMINE MALEATEPVT FORMANDA 080786—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — - CHLORPHENIRAMINE MALEATEROXANEANDA 080626—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — - CHLORPHENIRAMINE MALEATESUN PHARM INDUSTRIESANDA 080700—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — - CHLORPHENIRAMINE MALEATEVITARINEANDA 085837—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — - CHLORPHENIRAMINE MALEATEWATSON LABSANDA 080696—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — - CHLORPHENIRAMINE MALEATEWATSON LABSANDA 080791—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — - CHLORPHENIRAMINE MALEATEWATSON LABSANDA 085139—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — - CHLORPHENIRAMINE MALEATEWEST WARDANDA 083787—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — - HALSEYANDA 083629—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — - LANNETTANDA 080846—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG 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
45 yr 2 mo ago
Most recent approval
17 yr 6 mo ago
Approvals span 1982–2009 across 40 FDA applications.
Brand (NDA) 615%
Generic (ANDA) 3485%
Chlorpheniramine maleate: 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
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- 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.
