FDA Orange Book · active-ingredient family
Aminophylline
Aminophylline: 3 brands, 63 generics; first approved Jan 06, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 63 ANDA applications approved.
Brands (NDA)
3
Generics (ANDA)
63
Listed patents
0
Presentations
75
Brand (NDA) products
Originator applications
- HOSPIRANDA 01892419844 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/100ML INJECTABLE INJECTION Discontinued — 200MG/100ML INJECTABLE INJECTION Discontinued — 400MG/100ML INJECTABLE INJECTION Discontinued — 500MG/100ML INJECTABLE INJECTION Discontinued — - FISONSNDA 0182321982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG/5ML ENEMA RECTAL Discontinued — - GD SEARLE LLCNDA 002386—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — 200MG TABLET ORAL Discontinued —
Generic (ANDA) products (63)
Abbreviated applications
- AMINOPHYLLINETEVA PARENTERALANDA 0811421991
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/ML INJECTABLE INJECTION Discontinued — - AMINOPHYLLINESMITH AND NEPHEWANDA 0884291985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/ML INJECTABLE INJECTION Discontinued — - AMINOPHYLLINESMITH AND NEPHEWANDA 0887491985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/ML INJECTABLE INJECTION Discontinued — - AMINOPHYLLINEABRAXIS PHARMANDA 0884071984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/ML INJECTABLE INJECTION Discontinued — - AMINOPHYLLINEPHARMA SERVE NYANDA 0873921983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/ML INJECTABLE INJECTION Discontinued — - AMINOPHYLLINEMORTON GROVEANDA 0881561983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 105MG/5ML SOLUTION ORAL Discontinued — - AMINOPHYLLINEINTL MEDICATIONANDA 0878671983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/ML INJECTABLE INJECTION Discontinued — - AMINOPHYLLINEINTL MEDICATIONANDA 0878681983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/ML INJECTABLE INJECTION Discontinued — - AMINOPHYLLINERLDRSHOSPIRAANDA 0872421983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/ML INJECTABLE INJECTION Rx — - AMINOPHYLLINEVANGARDANDA 0883141983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - AMINOPHYLLINEVANGARDANDA 0883191983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued — - AMINOPHYLLINEABRAXIS PHARMANDA 0878861983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/ML INJECTABLE INJECTION Discontinued — - AMINOPHYLLINEROXANEANDA 0881261983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 105MG/5ML SOLUTION ORAL Discontinued — - AMINOPHYLLINEBARRANDA 0882971983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - AMINOPHYLLINEBARRANDA 0882981983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued — - AMINOPHYLLINEPHARMA SERVE NYANDA 0873871983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/ML INJECTABLE INJECTION Discontinued — - HOSPIRAANDA 08814719832 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/100ML INJECTABLE INJECTION Discontinued — 200MG/100ML INJECTABLE INJECTION Discontinued — - AMINOPHYLLINEDURAMED PHARMS BARRANDA 0881821983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - AMINOPHYLLINEDURAMED PHARMS BARRANDA 0881831983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued — - COSETTE PHARMS NCANDA 08549819832 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG SUPPOSITORY RECTAL Discontinued — 500MG SUPPOSITORY RECTAL Discontinued — - AMINOPHYLLINEHOSPIRAANDA 0876011982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/ML INJECTABLE INJECTION Discontinued — - AMINOPHYLLINRLDGD SEARLE LLCANDA 0872431982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/ML INJECTABLE INJECTION Discontinued — - AMINOPHYLLINRLDGD SEARLE LLCANDA 0876211982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/ML INJECTABLE INJECTION Discontinued — - ACTAVIS MID ATLANTICANDA 0877271982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 105MG/5ML SOLUTION ORAL Discontinued — - AMINOPHYLLINEASCOTANDA 0875221982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - AMINOPHYLLINEASCOTANDA 0875231982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued — - AMINOPHYLLINEROXANEANDA 0875001982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - AMINOPHYLLINEROXANEANDA 0875011982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued — - AMINOPHYLLINEINTL MEDICATIONANDA 0872091982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/ML INJECTABLE INJECTION Discontinued — - AMINOPHYLLINEABRAXIS PHARMANDA 0872501982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/ML INJECTABLE INJECTION Discontinued — - AMINOPHYLLINEABRAXIS PHARMANDA 084568—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/ML INJECTABLE INJECTION Discontinued — - AMINOPHYLLINEABRAXIS PHARMANDA 087200—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/ML INJECTABLE INJECTION Discontinued — - AMINOPHYLLINEAM REGENTANDA 087600—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/ML INJECTABLE INJECTION Discontinued — - AMINOPHYLLINEELKINS SINNANDA 087239—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/ML INJECTABLE INJECTION Discontinued — - AMINOPHYLLINEKING PHARMSANDA 086606—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/ML INJECTABLE INJECTION Discontinued — - AMINOPHYLLINELUITPOLDANDA 087240—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/ML INJECTABLE INJECTION Discontinued — - AMINOPHYLLINELYPHOMEDANDA 087431—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/ML INJECTABLE INJECTION Discontinued — - FISONSANDA 086466—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 105MG/5ML SOLUTION ORAL Discontinued — - FISONSANDA 087045—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 105MG/5ML SOLUTION ORAL Discontinued — - AMINOPHYLLINEIMPAX LABSANDA 084577—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, DELAYED RELEASE ORAL Discontinued — - AMINOPHYLLINEIMPAX LABSANDA 084575—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET, DELAYED RELEASE ORAL Discontinued — - AMINOPHYLLINETABLICAPSANDA 084632—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, DELAYED RELEASE ORAL Discontinued — - AMINOPHYLLINEVALEANDA 084531—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, DELAYED RELEASE ORAL Discontinued — - AMINOPHYLLINEVALEANDA 084530—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET, DELAYED RELEASE ORAL Discontinued — - PHARM RES ASSOCANDA 086760—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 225MG TABLET, EXTENDED RELEASE ORAL Discontinued — - AMINOPHYLLINEANI PHARMSANDA 085261—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - AMINOPHYLLINECHARTWELL MOLECULARANDA 084588—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — 200MG TABLET ORAL Discontinued — - AMINOPHYLLINEHALSEYANDA 084674—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - AMINOPHYLLINEHIKMA INTL PHARMSANDA 084540—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - AMINOPHYLLINEHIKMA INTL PHARMSANDA 085003—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued — - AMINOPHYLLINEIMPAX LABSANDA 084574—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - AMINOPHYLLINEIMPAX LABSANDA 084576—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued — - AMINOPHYLLINEKV PHARMANDA 085284—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - AMINOPHYLLINEKV PHARMANDA 085289—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued — - AMINOPHYLLINEPAL PAKANDA 084533—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - AMINOPHYLLINEPANRAYANDA 084552—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — 200MG TABLET ORAL Discontinued — - AMINOPHYLLINEPUREPAC PHARMANDA 084699—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - AMINOPHYLLINEPUREPAC PHARMANDA 085333—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued — - AMINOPHYLLINEVALEANT PHARM INTLANDA 084563—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued — - AMINOPHYLLINEVINTAGE PHARMSANDA 085409—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - AMINOPHYLLINEVINTAGE PHARMSANDA 085410—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued — - AMINOPHYLLINEWATSON LABSANDA 085567—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - AMINOPHYLLINEWATSON LABSANDA 085564—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG 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 3 mo ago
Most recent approval
35 yr 5 mo ago
Approvals span 1982–1991 across 66 FDA applications.
Brand (NDA) 35%
Generic (ANDA) 6395%
Aminophylline: 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 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
