Details for New Drug Application (NDA): 081265
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NDA 081265 describes BENZTROPINE MESYLATE, which is a drug marketed by Fresenius Kabi Usa, Hikma, Hikma Farmaceutica, Luitpold, Navinta Llc, Aiping Pharm Inc, Chartwell Rx, Endo Operations, Epic Pharma Llc, Invagen Pharms, Lannett Co Inc, Leading, Nuvo Pharm, Oxford Pharms, Pliva, Quantum Pharmics, and Usl Pharma, and is included in twenty-seven NDAs. It is available from twenty 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 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 suppliers are listed for this compound. Additional details are available on the benztropine mesylate profile page.
Summary for 081265
| Tradename: | BENZTROPINE MESYLATE |
| Applicant: | Chartwell Rx |
| Ingredient: | benztropine mesylate |
| Patents: | 0 |
Pharmacology for NDA: 081265
| Mechanism of Action | Cholinergic Antagonists Histamine Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 081265
Suppliers and Packaging for NDA: 081265
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BENZTROPINE MESYLATE | benztropine mesylate | TABLET;ORAL | 081265 | ANDA | Chartwell RX, LLC. | 62135-141 | 62135-141-18 | 180 TABLET in 1 BOTTLE (62135-141-18) |
| BENZTROPINE MESYLATE | benztropine mesylate | TABLET;ORAL | 081265 | ANDA | Chartwell RX, LLC. | 62135-141 | 62135-141-57 | 540 TABLET in 1 BOTTLE (62135-141-57) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
| Approval Date: | Jan 23, 1992 | TE: | AA | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
| Approval Date: | Jan 23, 1992 | TE: | AA | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.5MG | ||||
| Approval Date: | Nov 29, 2023 | TE: | AA | RLD: | No | ||||
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