Assyro AI

FDA Orange Book · active-ingredient family

Aminophylline

Aminophylline is approved as 3 brand and 63 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:AMINOPHYLLINE IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER · NDA 018924

3

Brand (NDA)

63

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · enema, injectable, solution, suppository, tablet, tablet, delayed release, tablet, extended release

ProductApplicantApplicationTEApproved
AMINOPHYLLINE IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER×4HOSPIRANDA 018924—Dec 12, 1984
SOMOPHYLLINFISONSNDA 018232—Apr 02, 1982
AMINOPHYLLIN×2GD SEARLE LLCNDA 002386—Approved Prior to Jan 1, 1982

Generic (ANDA) products (63)

ProductApplicantApplicationTEApproved
AMINOPHYLLINETEVA PARENTERALANDA 081142—Sep 25, 1991
AMINOPHYLLINESMITH AND NEPHEWANDA 088429—May 30, 1985
AMINOPHYLLINESMITH AND NEPHEWANDA 088749—May 30, 1985
AMINOPHYLLINEABRAXIS PHARMANDA 088407—Jan 25, 1984
AMINOPHYLLINEPHARMA SERVE NYANDA 087392—Dec 15, 1983
AMINOPHYLLINEMORTON GROVEANDA 088156—Dec 05, 1983
AMINOPHYLLINEINTL MEDICATIONANDA 087867—Nov 10, 1983
AMINOPHYLLINEINTL MEDICATIONANDA 087868—Nov 10, 1983
AMINOPHYLLINERLDHOSPIRAANDA 087242—Oct 26, 1983
AMINOPHYLLINEVANGARDANDA 088314—Oct 03, 1983
AMINOPHYLLINEVANGARDANDA 088319—Oct 03, 1983
AMINOPHYLLINEABRAXIS PHARMANDA 087886—Aug 30, 1983
AMINOPHYLLINEROXANEANDA 088126—Aug 19, 1983
AMINOPHYLLINEBARRANDA 088297—Aug 19, 1983
AMINOPHYLLINEBARRANDA 088298—Aug 19, 1983
AMINOPHYLLINEPHARMA SERVE NYANDA 087387—Jun 03, 1983
AMINOPHYLLINE IN SODIUM CHLORIDE 0.45%×2HOSPIRAANDA 088147—May 03, 1983
AMINOPHYLLINEDURAMED PHARMS BARRANDA 088182—Mar 31, 1983
AMINOPHYLLINEDURAMED PHARMS BARRANDA 088183—Mar 31, 1983
TRUPHYLLINE×2COSETTE PHARMS NCANDA 085498—Mar 23, 1983
AMINOPHYLLINEHOSPIRAANDA 087601—Jul 23, 1982
AMINOPHYLLINRLDGD SEARLE LLCANDA 087243—May 24, 1982
AMINOPHYLLINRLDGD SEARLE LLCANDA 087621—May 24, 1982
AMINOPHYLLINE DYE FREEACTAVIS MID ATLANTICANDA 087727—Apr 16, 1982
AMINOPHYLLINEASCOTANDA 087522—Feb 12, 1982
AMINOPHYLLINEASCOTANDA 087523—Feb 12, 1982
AMINOPHYLLINEROXANEANDA 087500—Feb 09, 1982
AMINOPHYLLINEROXANEANDA 087501—Feb 09, 1982
AMINOPHYLLINEINTL MEDICATIONANDA 087209—Feb 01, 1982
AMINOPHYLLINEABRAXIS PHARMANDA 087250—Jan 06, 1982
AMINOPHYLLINEABRAXIS PHARMANDA 084568—Approved Prior to Jan 1, 1982
AMINOPHYLLINEABRAXIS PHARMANDA 087200—Approved Prior to Jan 1, 1982
AMINOPHYLLINEAM REGENTANDA 087600—Approved Prior to Jan 1, 1982
AMINOPHYLLINEELKINS SINNANDA 087239—Approved Prior to Jan 1, 1982
AMINOPHYLLINEKING PHARMSANDA 086606—Approved Prior to Jan 1, 1982
AMINOPHYLLINELUITPOLDANDA 087240—Approved Prior to Jan 1, 1982
AMINOPHYLLINELYPHOMEDANDA 087431—Approved Prior to Jan 1, 1982
SOMOPHYLLINFISONSANDA 086466—Approved Prior to Jan 1, 1982
SOMOPHYLLIN-DFFISONSANDA 087045—Approved Prior to Jan 1, 1982
AMINOPHYLLINEIMPAX LABSANDA 084577—Approved Prior to Jan 1, 1982
AMINOPHYLLINEIMPAX LABSANDA 084575—Approved Prior to Jan 1, 1982
AMINOPHYLLINETABLICAPSANDA 084632—Approved Prior to Jan 1, 1982
AMINOPHYLLINEVALEANDA 084531—Approved Prior to Jan 1, 1982
AMINOPHYLLINEVALEANDA 084530—Approved Prior to Jan 1, 1982
PHYLLOCONTINPHARM RES ASSOCANDA 086760—Approved Prior to Jan 1, 1982
AMINOPHYLLINE×2ANI PHARMSANDA 085261—Approved Prior to Jan 1, 1982
AMINOPHYLLINE×2CHARTWELL MOLECULARANDA 084588—Approved Prior to Jan 1, 1982
AMINOPHYLLINEHALSEYANDA 084674—Approved Prior to Jan 1, 1982
AMINOPHYLLINEHIKMA INTL PHARMSANDA 084540—Approved Prior to Jan 1, 1982
AMINOPHYLLINEHIKMA INTL PHARMSANDA 085003—Approved Prior to Jan 1, 1982
AMINOPHYLLINEIMPAX LABSANDA 084574—Approved Prior to Jan 1, 1982
AMINOPHYLLINEIMPAX LABSANDA 084576—Approved Prior to Jan 1, 1982
AMINOPHYLLINEKV PHARMANDA 085284—Approved Prior to Jan 1, 1982
AMINOPHYLLINEKV PHARMANDA 085289—Approved Prior to Jan 1, 1982
AMINOPHYLLINEPAL PAKANDA 084533—Approved Prior to Jan 1, 1982
AMINOPHYLLINE×2PANRAYANDA 084552—Approved Prior to Jan 1, 1982
AMINOPHYLLINEPUREPAC PHARMANDA 084699—Approved Prior to Jan 1, 1982
AMINOPHYLLINEPUREPAC PHARMANDA 085333—Approved Prior to Jan 1, 1982
AMINOPHYLLINEVALEANT PHARM INTLANDA 084563—Approved Prior to Jan 1, 1982
AMINOPHYLLINEVINTAGE PHARMSANDA 085409—Approved Prior to Jan 1, 1982
AMINOPHYLLINEVINTAGE PHARMSANDA 085410—Approved Prior to Jan 1, 1982
AMINOPHYLLINEWATSON LABSANDA 085567—Approved Prior to Jan 1, 1982
AMINOPHYLLINEWATSON LABSANDA 085564—Approved Prior to Jan 1, 1982

Listed patents

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.

Aminophylline — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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