Details for New Drug Application (NDA): 208769
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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 208769
Tradename: | SCOPOLAMINE |
Applicant: | Actavis Labs Ut Inc |
Ingredient: | scopolamine |
Patents: | 0 |
Pharmacology for NDA: 208769
Mechanism of Action | Cholinergic Antagonists |
Suppliers and Packaging for NDA: 208769
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SCOPOLAMINE | scopolamine | SYSTEM;TRANSDERMAL | 208769 | ANDA | Actavis Pharma, Inc. | 0591-2258 | 0591-2258-04 | 4 POUCH in 1 CARTON (0591-2258-04) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH |
SCOPOLAMINE | scopolamine | SYSTEM;TRANSDERMAL | 208769 | ANDA | Actavis Pharma, Inc. | 0591-2258 | 0591-2258-23 | 24 POUCH in 1 CARTON (0591-2258-23) / 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: | Jan 10, 2022 | TE: | AB | RLD: | No |
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