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Benztropine mesylateis the generic ingredient in two branded drugs marketed by Fresenius Kabi Usa, Hikma, Hikma Farmaceutica, Luitpold, Navinta Llc, Epic Pharma Llc, Aiping Pharm Inc, Aspen Global Inc, Chartwell Rx, Invagen Pharms, Lannett Co Inc, Leading, Oxford Pharms, Pliva, Quantum Pharmics, Usl Pharma, Vintage, and Merck, and is included in twenty-nine NDAs. Additional information is available in the individual branded drug profile pages.
There are seven drug master file entries for benztropine mesylate. Twenty suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for benztropine mesylate
|Drug Master File Entries:||7|
|Finished Product Suppliers / Packagers:||20|
|Raw Ingredient (Bulk) Api Vendors:||124|
|Formulation / Manufacturing:||see details|
|Drug Prices:||Drug price trends for benztropine mesylate|
|What excipients (inactive ingredients) are in benztropine mesylate?||benztropine mesylate excipients list|
|DailyMed Link:||benztropine mesylate at DailyMed|
Recent Clinical Trials for benztropine mesylate
Identify potential brand extensions & 505(b)(2) entrants
|Boehringer Ingelheim||Phase 2|
|National Institute of Allergy and Infectious Diseases (NIAID)||Phase 2|
Generic filers with tentative approvals for BENZTROPINE MESYLATE
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for benztropine mesylate
|Mechanism of Action||Cholinergic Antagonists|
Histamine Receptor Antagonists
Medical Subject Heading (MeSH) Categories for benztropine mesylate
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||TE||Type||RLD||RS||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|Chartwell Rx||BENZTROPINE MESYLATE||benztropine mesylate||TABLET;ORAL||081265-001||Jan 23, 1992||AA||RX||No||No||⤷ Try a Trial||⤷ Try a Trial||⤷ Try a Trial|
|Leading||BENZTROPINE MESYLATE||benztropine mesylate||TABLET;ORAL||090168-003||Nov 28, 2012||AA||RX||No||No||⤷ Try a Trial||⤷ Try a Trial||⤷ Try a Trial|
|Epic Pharma Llc||BENZTROPINE MESYLATE||benztropine mesylate||TABLET;ORAL||072265-001||Feb 27, 1989||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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