Details for New Drug Application (NDA): 216786
✉ Email this page to a colleague
NDA 216786 describes METHSCOPOLAMINE BROMIDE, which is a drug marketed by Bayshore Pharms Llc, Breckenridge Pharm, Chartwell Rx, Ne Rx Pharma, and Pvt Form, and is included in five NDAs. It is available from four suppliers. Additional details are available on the METHSCOPOLAMINE BROMIDE profile page.
The generic ingredient in METHSCOPOLAMINE BROMIDE is methscopolamine bromide. There are seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the methscopolamine bromide profile page.
The generic ingredient in METHSCOPOLAMINE BROMIDE is methscopolamine bromide. There are seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the methscopolamine bromide profile page.
Summary for 216786
| Tradename: | METHSCOPOLAMINE BROMIDE |
| Applicant: | Ne Rx Pharma |
| Ingredient: | methscopolamine bromide |
| Patents: | 0 |
Pharmacology for NDA: 216786
| Mechanism of Action | Cholinergic Antagonists |
Suppliers and Packaging for NDA: 216786
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| METHSCOPOLAMINE BROMIDE | methscopolamine bromide | TABLET;ORAL | 216786 | ANDA | Aarkish Pharmaceuticals NJ Inc. | 81005-127 | 81005-127-01 | 100 TABLET in 1 BOTTLE (81005-127-01) |
| METHSCOPOLAMINE BROMIDE | methscopolamine bromide | TABLET;ORAL | 216786 | ANDA | Aarkish Pharmaceuticals NJ Inc. | 81005-127 | 81005-127-10 | 1000 TABLET in 1 BOTTLE (81005-127-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
| Approval Date: | Feb 1, 2024 | TE: | AA | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Feb 1, 2024 | TE: | AA | RLD: | No | ||||
Complete Access Available with Subscription
