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Last Updated: March 7, 2021

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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, Akorn, Alcon Labs Inc, Accord Hlthcare, Hospira, Intl Medication Sys, Fresenius Kabi Usa, Sebela Ireland Ltd, Scherer Rp, Medpointe Pharm Hlc, Hikma, Alpharma Us Pharms, Gd Searle Llc, Md Pharm, Able, Ani Pharms Inc, Ascot, Bayshore Pharms Llc, Eci Pharms Llc, Fosun Pharma, Heather, Inwood Labs, Kv Pharm, Lannett, Leading Pharma Llc, Lederle, Mayne Pharma Inc, Mylan, Par Pharm, Parke Davis, Pvt Form, R And S Pharma, Roxane, Specgx Llc, Sun Pharm Industries, Upsher Smith Labs, Usl Pharma, Valeant Pharm Intl, Watson Labs, Vangard, Superpharm, Pfizer, Halsey, Mylan Institutional, Abbvie, and Wyeth Ayerst, and is included in fifty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-three drug master file entries for atropine sulfate. Nine suppliers are listed for this compound.

Summary for atropine sulfate
US Patents:0
Tradenames:17
Applicants:46
NDAs:52
Drug Master File Entries: 23
Suppliers / Packagers: 9
Bulk Api Vendors: 111
Clinical Trials: 30
Patent Applications: 6,311
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in atropine sulfate?atropine sulfate excipients list
DailyMed Link:atropine sulfate at DailyMed
Recent Clinical Trials for atropine sulfate

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

SponsorPhase
University of Sao Paulo General HospitalPhase 3
Fayoum UniversityPhase 1
Ain Shams UniversityN/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
Mylan Institutional ENLON-PLUS atropine sulfate; edrophonium chloride INJECTABLE;INJECTION 019678-001 Nov 6, 1991 DISCN Yes No   Start Trial   Start Trial   Start Trial
Ascot DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE atropine sulfate; diphenoxylate hydrochloride TABLET;ORAL 087934-001 Jul 19, 1983 DISCN No No   Start Trial   Start Trial   Start Trial
Abbvie ATROPINE AND DEMEROL atropine sulfate; meperidine hydrochloride INJECTABLE;INJECTION 087847-001 Nov 26, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Hospira ATROPINE SULFATE atropine sulfate SOLUTION;INTRAVENOUS 021146-005 Aug 17, 2017 AA RX Yes Yes   Start Trial   Start Trial   Start 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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