Details for New Drug Application (NDA): 217893
The generic ingredient in SCOPOLAMINE is scopolamine. There is one drug master file entry for this compound. Twelve suppliers are listed for this compound. Additional details are available on the scopolamine profile page.
Summary for 217893
| Tradename: | SCOPOLAMINE |
| Applicant: | Zydus Pharms |
| Ingredient: | scopolamine |
| Patents: | 0 |
Pharmacology for NDA: 217893
| Mechanism of Action | Cholinergic Antagonists |
Suppliers and Packaging for NDA: 217893
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SCOPOLAMINE | scopolamine | SYSTEM;TRANSDERMAL | 217893 | ANDA | A-S Medication Solutions | 50090-8154 | 50090-8154-0 | 4 POUCH in 1 CARTON (50090-8154-0) / 1 d in 1 POUCH |
| SCOPOLAMINE | scopolamine | SYSTEM;TRANSDERMAL | 217893 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1846 | 70710-1846-2 | 10 POUCH in 1 CARTON (70710-1846-2) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SYSTEM;TRANSDERMAL | Strength | 1MG/72HR | ||||
| Approval Date: | Aug 29, 2024 | TE: | AB | RLD: | No | ||||
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