Details for New Drug Application (NDA): 212694
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NDA 212694 describes BENZTROPINE MESYLATE, which is a drug marketed by Fresenius Kabi Usa, Hikma, Hikma Farmaceutica, Luitpold, Navinta Llc, Aiping Pharm Inc, Chartwell Rx, Epic Pharma Llc, Invagen Pharms, Lannett Co Inc, Leading, Nuvo Pharm, Oxford Pharms, Ph Health, Pliva, Quagen, Quantum Pharmics, and Usl Pharma, and is included in twenty-eight NDAs. It is available from twenty-one suppliers. Additional details are available on the BENZTROPINE MESYLATE profile page.
The generic ingredient in BENZTROPINE MESYLATE is benztropine mesylate. There are seven drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the benztropine mesylate profile page.
The generic ingredient in BENZTROPINE MESYLATE is benztropine mesylate. There are seven drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the benztropine mesylate profile page.
Summary for 212694
| Tradename: | BENZTROPINE MESYLATE |
| Applicant: | Quagen |
| Ingredient: | benztropine mesylate |
| Patents: | 0 |
Pharmacology for NDA: 212694
| Mechanism of Action | Cholinergic Antagonists Histamine Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 212694
Suppliers and Packaging for NDA: 212694
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BENZTROPINE MESYLATE | benztropine mesylate | TABLET;ORAL | 212694 | ANDA | QUAGEN PHARMACEUTICALS LLC | 70752-123 | 70752-123-10 | 100 TABLET in 1 BOTTLE, PLASTIC (70752-123-10) |
| BENZTROPINE MESYLATE | benztropine mesylate | TABLET;ORAL | 212694 | ANDA | QUAGEN PHARMACEUTICALS LLC | 70752-123 | 70752-123-11 | 1000 TABLET in 1 BOTTLE, PLASTIC (70752-123-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.5MG | ||||
| Approval Date: | Feb 11, 2025 | TE: | AA | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
| Approval Date: | Feb 11, 2025 | TE: | AA | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
| Approval Date: | Feb 11, 2025 | TE: | AA | RLD: | No | ||||
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