Details for New Drug Application (NDA): 215329
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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 215329
Tradename: | SCOPOLAMINE |
Applicant: | Rhodes Pharms |
Ingredient: | scopolamine |
Patents: | 0 |
Pharmacology for NDA: 215329
Mechanism of Action | Cholinergic Antagonists |
Suppliers and Packaging for NDA: 215329
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SCOPOLAMINE | scopolamine | SYSTEM;TRANSDERMAL | 215329 | ANDA | Rhodes Pharmaceuticals L.P. | 42858-150 | 42858-150-14 | 10 POUCH in 1 BOX (42858-150-14) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH |
SCOPOLAMINE | scopolamine | SYSTEM;TRANSDERMAL | 215329 | ANDA | Rhodes Pharmaceuticals L.P. | 42858-150 | 42858-150-40 | 4 POUCH in 1 BOX (42858-150-40) / 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: | May 6, 2024 | TE: | AB | RLD: | No |
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