Details for New Drug Application (NDA): 216120
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The generic ingredient in ATROPINE SULFATE is atropine sulfate. There are twenty-three drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the atropine sulfate profile page.
Summary for 216120
Tradename: | ATROPINE SULFATE |
Applicant: | Am Regent |
Ingredient: | atropine sulfate |
Patents: | 0 |
Pharmacology for NDA: 216120
Mechanism of Action | Cholinergic Antagonists Cholinergic Muscarinic Antagonists |
Suppliers and Packaging for NDA: 216120
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ATROPINE SULFATE | atropine sulfate | SOLUTION;INTRAVENOUS | 216120 | ANDA | Henry Schein, Inc | 0404-9802 | 0404-9802-01 | 1 VIAL, GLASS in 1 BAG (0404-9802-01) / 1 mL in 1 VIAL, GLASS |
ATROPINE SULFATE | atropine sulfate | SOLUTION;INTRAVENOUS | 216120 | ANDA | American Regent, Inc. | 0517-1001 | 0517-1001-25 | 25 VIAL, GLASS in 1 TRAY (0517-1001-25) / 1 mL in 1 VIAL, GLASS (0517-1001-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 0.4MG/ML (0.4MG/ML) | ||||
Approval Date: | May 26, 2022 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 1MG/ML (1MG/ML) | ||||
Approval Date: | May 26, 2022 | TE: | AP | RLD: | No |
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