Details for New Drug Application (NDA): 212868
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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 212868
Tradename: | ATROPINE SULFATE |
Applicant: | Accord Hlthcare |
Ingredient: | atropine sulfate |
Patents: | 0 |
Pharmacology for NDA: 212868
Mechanism of Action | Cholinergic Antagonists Cholinergic Muscarinic Antagonists |
Suppliers and Packaging for NDA: 212868
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ATROPINE SULFATE | atropine sulfate | SOLUTION;INTRAVENOUS | 212868 | ANDA | Accord Healthcare, Inc., | 16729-483 | 16729-483-03 | 10 SYRINGE, GLASS in 1 CARTON (16729-483-03) / 5 mL in 1 SYRINGE, GLASS |
ATROPINE SULFATE | atropine sulfate | SOLUTION;INTRAVENOUS | 212868 | ANDA | Accord Healthcare, Inc., | 16729-483 | 16729-483-31 | 5 mL in 1 SYRINGE, GLASS (16729-483-31) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 0.25MG/5ML (0.05MG/ML) | ||||
Approval Date: | Jul 26, 2021 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 0.5MG/5ML (0.1MG/ML) | ||||
Approval Date: | Jul 26, 2021 | TE: | AP | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 1MG/10ML (0.1MG/ML) | ||||
Approval Date: | Jul 26, 2021 | TE: | AP | RLD: | No |
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