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Last Updated: March 1, 2024

Atropine sulfate - Generic Drug Details


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What are the generic drug sources for atropine sulfate and what is the scope of freedom to operate?

Atropine sulfate is the generic ingredient in seventeen branded drugs marketed by Us Army, Amneal, Apotex, Bausch And Lomb Inc, Mankind Pharma, Rising, Alcon Labs Inc, Accord Hlthcare, Am Regent, Hospira, Intl Medication Sys, Medefil Inc, Fresenius Kabi Usa, Hikma, Sebela Ireland Ltd, Scherer Rp, Medpointe Pharm Hlc, Alpharma Us Pharms, Gd Searle Llc, Md Pharm, Able, Ani Pharms, Ascot, Bayshore Pharms Llc, Chartwell Rx, Dr Reddys Labs Sa, Fosun Pharma, Heather, Inwood Labs, Kv Pharm, Lannett, Leading, Lederle, Mylan, Parke Davis, Pvt Form, R And S Pharma, Roxane, Specgx Llc, Strides Pharma, Sun Pharm Industries, Upsher Smith Labs, Usl Pharma, Valeant Pharm Intl, Watson Labs, Winder Labs Llc, Vangard, Superpharm, Pfizer, Halsey, Mylan Institutional, Abbvie, and Wyeth Ayerst, and is included in sixty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for atropine sulfate. Twenty-one suppliers are listed for this compound.

Summary for atropine sulfate
Recent Clinical Trials for atropine sulfate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Zhaoke (Hong Kong) Ophthalmology Pharmaceutical LimitedPhase 1
Peking University People's HospitalN/A
Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineN/A

See all atropine sulfate clinical trials

US Patents and Regulatory Information for atropine sulfate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sebela Ireland Ltd MOTOFEN HALF-STRENGTH atropine sulfate; difenoxin hydrochloride TABLET;ORAL 017744-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Gd Searle Llc LOMOTIL atropine sulfate; diphenoxylate hydrochloride SOLUTION;ORAL 012699-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Superpharm LOGEN atropine sulfate; diphenoxylate hydrochloride TABLET;ORAL 088962-001 May 10, 1985 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Fosun Pharma DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE atropine sulfate; diphenoxylate hydrochloride TABLET;ORAL 086173-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan Institutional ENLON-PLUS atropine sulfate; edrophonium chloride INJECTABLE;INJECTION 019677-001 Nov 6, 1991 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Chartwell Rx DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE atropine sulfate; diphenoxylate hydrochloride TABLET;ORAL 207128-001 Oct 21, 2020 AA RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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