Details for New Drug Application (NDA): 021146
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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-two suppliers are listed for this compound. Additional details are available on the atropine sulfate profile page.
Summary for 021146
Tradename: | ATROPINE SULFATE |
Applicant: | Hospira |
Ingredient: | atropine sulfate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 021146
Mechanism of Action | Cholinergic Antagonists Cholinergic Muscarinic Antagonists |
Suppliers and Packaging for NDA: 021146
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ATROPINE SULFATE | atropine sulfate | SOLUTION;INTRAVENOUS | 021146 | NDA | Henry Schein, Inc. | 0404-9823 | 0404-9823-05 | 1 SYRINGE, PLASTIC in 1 BAG (0404-9823-05) / 5 mL in 1 SYRINGE, PLASTIC |
ATROPINE SULFATE | atropine sulfate | SOLUTION;INTRAVENOUS | 021146 | NDA | Hospira, Inc. | 0409-1630 | 0409-1630-10 | 10 CARTON in 1 PACKAGE (0409-1630-10) / 1 SYRINGE, PLASTIC in 1 CARTON / 10 mL in 1 SYRINGE, PLASTIC (0409-1630-15) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Jul 9, 2001 | TE: | AP | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 0.25MG/5ML (0.05MG/ML) | ||||
Approval Date: | Jul 9, 2001 | TE: | AP | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 1MG/10ML (0.1MG/ML) | ||||
Approval Date: | Jul 9, 2001 | TE: | AP | RLD: | Yes |
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