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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
Sponsor | Phase |
---|---|
University of Sao Paulo General Hospital | Phase 3 |
Fayoum University | Phase 1 |
Ain Shams University | N/A |
Pharmacology for atropine sulfate
Drug Class | Anticholinergic Cholinergic Muscarinic Antagonist |
Mechanism of Action | Cholinergic Antagonists Cholinergic Muscarinic Antagonists |
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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