Details for New Drug Application (NDA): 078830
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NDA 078830 describes SCOPOLAMINE, which is a drug marketed by Actavis Labs Ut Inc, Mylan Technologies, Padagis Us, Rhodes Pharms, Riconpharma Llc, and Zydus Pharms, and is included in six NDAs. It is available from nine suppliers. Additional details are available on the SCOPOLAMINE profile page.
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.
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 078830
| Tradename: | SCOPOLAMINE |
| Applicant: | Padagis Us |
| Ingredient: | scopolamine |
| Patents: | 0 |
Pharmacology for NDA: 078830
| Mechanism of Action | Cholinergic Antagonists |
Suppliers and Packaging for NDA: 078830
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SCOPOLAMINE | scopolamine | SYSTEM;TRANSDERMAL | 078830 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-580 | 45802-580-01 | 1 PATCH, EXTENDED RELEASE in 1 POUCH (45802-580-01) |
| SCOPOLAMINE | scopolamine | SYSTEM;TRANSDERMAL | 078830 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-580 | 45802-580-46 | 10 POUCH in 1 CARTON (45802-580-46) / 1 PATCH, EXTENDED RELEASE in 1 POUCH |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SYSTEM;TRANSDERMAL | Strength | 1MG/72HR | ||||
| Approval Date: | Jan 30, 2015 | TE: | AB | RLD: | No | ||||
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