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Last Updated: December 1, 2022

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, Amneal, Apotex Inc, Bausch And Lomb Inc, Alcon Labs Inc, Accord Hlthcare, Am Regent, Hospira, Intl Medication Sys, 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, Fosun Pharma, Heather, Inwood Labs, Kv Pharm, Lannett, Leading, Lederle, Mayne Pharma Inc, 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-one NDAs. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for atropine sulfate. Seventeen suppliers are listed for this compound.

Summary for atropine sulfate
Recent Clinical Trials for atropine sulfate

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SponsorPhase
Shanghai Eye Disease Prevention and Treatment CenterN/A
Peking University People's HospitalN/A
Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineN/A

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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
Fosun Pharma DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE atropine sulfate; diphenoxylate hydrochloride TABLET;ORAL 086173-001 Approved Prior to Jan 1, 1982 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan ENLON-PLUS atropine sulfate; edrophonium chloride INJECTABLE;INJECTION 019678-001 Nov 6, 1991 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hospira ATROPINE SULFATE atropine sulfate SOLUTION;INTRAVENOUS 021146-001 Jul 9, 2001 AP RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amneal ATROPINE SULFATE atropine sulfate SOLUTION;INTRAVENOUS 215342-001 Jan 26, 2022 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Intl Medication Sys ATROPINE SULFATE atropine sulfate SOLUTION;INTRAVENOUS 212461-001 Oct 5, 2020 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Wyeth Ayerst MEPERIDINE AND ATROPINE SULFATE atropine sulfate; meperidine hydrochloride INJECTABLE;INJECTION 085121-002 Approved Prior to Jan 1, 1982 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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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