Details for New Drug Application (NDA): 203753
✉ Email this page to a colleague
The generic ingredient in SCOPOLAMINE is scopolamine. There are twenty-one drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the scopolamine profile page.
Summary for 203753
Tradename: | SCOPOLAMINE |
Applicant: | Mylan Technologies |
Ingredient: | scopolamine |
Patents: | 0 |
Pharmacology for NDA: 203753
Mechanism of Action | Cholinergic Antagonists |
Suppliers and Packaging for NDA: 203753
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SCOPOLAMINE | scopolamine | SYSTEM;TRANSDERMAL | 203753 | ANDA | Mylan Pharmaceuticals Inc. | 0378-6470 | 0378-6470-44 | 24 POUCH in 1 CARTON (0378-6470-44) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH |
SCOPOLAMINE | scopolamine | SYSTEM;TRANSDERMAL | 203753 | ANDA | Mylan Pharmaceuticals Inc. | 0378-6470 | 0378-6470-97 | 10 POUCH in 1 CARTON (0378-6470-97) / 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: | Jun 19, 2019 | TE: | AB | RLD: | No |
Complete Access Available with Subscription