Assyro AI

FDA Orange Book · active-ingredient family

Atropine sulfate; diphenoxylate hydrochloride

Atropine sulfate; diphenoxylate hydrochloride is approved as 2 brand and 37 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:LOMOTIL · NDA 012462

2

Brand (NDA)

37

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, solution, tablet

ProductApplicantApplicationTEApproved
LOMOTILRLDPFIZERNDA 012462AAApproved Prior to Jan 1, 1982
LOMOTILGD SEARLE LLCNDA 012699—Approved Prior to Jan 1, 1982

Generic (ANDA) products (37)

ProductApplicantApplicationTEApproved
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEWINDER LABS LLCANDA 211362AAJan 27, 2021
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATECHARTWELL RXANDA 207128AAOct 21, 2020
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATESPECGX LLCANDA 213335AAOct 06, 2020
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEDR REDDYS LABS SAANDA 210789—Jun 03, 2020
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATELEADINGANDA 213413AAFeb 20, 2020
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEUNICHEMANDA 210819AANov 13, 2018
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEQUAGENANDA 210571—Aug 31, 2018
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEABLEANDA 040395—Nov 27, 2000
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATESTRIDES PHARMA INTLANDA 040357—May 02, 2000
LOGENSUPERPHARMANDA 088962—May 10, 1985
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEASCOTANDA 087934—Jul 19, 1983
LO-TROLVANGARDANDA 088009—Mar 25, 1983
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATERLDHIKMAANDA 087708—May 03, 1982
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEUSL PHARMAANDA 087842—Mar 29, 1982
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEHIKMAANDA 087765—Mar 15, 1982
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEVALEANT PHARM INTLANDA 087195—Feb 16, 1982
DIPHENOXYLATE HYDROCHLORIDE W/ ATROPINE SULFATESCHERER RPANDA 086440—Approved Prior to Jan 1, 1982
COLONAIDMEDPOINTE PHARM HLCANDA 085735—Approved Prior to Jan 1, 1982
LOMANATEALPHARMA US PHARMSANDA 085746—Approved Prior to Jan 1, 1982
COLONAIDMEDPOINTE PHARM HLCANDA 085737—Approved Prior to Jan 1, 1982
DI-ATROMD PHARMANDA 085266—Approved Prior to Jan 1, 1982
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEANI PHARMSANDA 086727AAApproved Prior to Jan 1, 1982
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEFOSUN PHARMAANDA 086173—Approved Prior to Jan 1, 1982
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEHEATHERANDA 086798—Approved Prior to Jan 1, 1982
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEINWOOD LABSANDA 085509—Approved Prior to Jan 1, 1982
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEKV PHARMANDA 085659—Approved Prior to Jan 1, 1982
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATELANNETTANDA 085372AAApproved Prior to Jan 1, 1982
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATELEDERLEANDA 086950—Approved Prior to Jan 1, 1982
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEPARKE DAVISANDA 087131—Approved Prior to Jan 1, 1982
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEPVT FORMANDA 085766—Approved Prior to Jan 1, 1982
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEQUAGENANDA 085762—Approved Prior to Jan 1, 1982
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATER AND S PHARMAANDA 085035—Approved Prior to Jan 1, 1982
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEROXANEANDA 086057—Approved Prior to Jan 1, 1982
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATESUN PHARM INDUSTRIESANDA 085506—Approved Prior to Jan 1, 1982
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEWATSON LABSANDA 085876—Approved Prior to Jan 1, 1982
LONOXFOSUN PHARMAANDA 085311—Approved Prior to Jan 1, 1982
LOW-QUELHALSEYANDA 085211—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.

Atropine sulfate; diphenoxylate hydrochloride — frequently asked questions

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

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