Details for New Drug Application (NDA): 212319
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NDA 212319 describes ATROPINE (AUTOINJECTOR), which is a drug marketed by Rafa Labs Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the ATROPINE (AUTOINJECTOR) profile page.
The generic ingredient in ATROPINE (AUTOINJECTOR) is atropine. There are twenty-three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the atropine profile page.
The generic ingredient in ATROPINE (AUTOINJECTOR) is atropine. There are twenty-three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the atropine profile page.
Summary for 212319
| Tradename: | ATROPINE (AUTOINJECTOR) |
| Applicant: | Rafa Labs Ltd |
| Ingredient: | atropine |
| Patents: | 0 |
Pharmacology for NDA: 212319
| Mechanism of Action | Cholinergic Antagonists Cholinergic Muscarinic Antagonists |
Medical Subject Heading (MeSH) Categories for 212319
Suppliers and Packaging for NDA: 212319
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ATROPINE (AUTOINJECTOR) | atropine | SOLUTION;INTRAMUSCULAR | 212319 | NDA | Rafa Laboratories, Ltd. | 71053-592 | 71053-592-01 | 480 CARTON in 1 BOX (71053-592-01) / 40 SYRINGE in 1 CARTON / .7 mL in 1 SYRINGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAMUSCULAR | Strength | EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML) | ||||
| Approval Date: | Jul 9, 2018 | TE: | RLD: | No | |||||
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