Details for New Drug Application (NDA): 017106
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NDA 017106 describes ATROPEN, which is a drug marketed by MMT and is included in one NDA. It is available from one supplier. Additional details are available on the ATROPEN profile page.
The generic ingredient in ATROPEN is atropine. There are twenty-three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the atropine profile page.
The generic ingredient in ATROPEN is atropine. There are twenty-three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the atropine profile page.
Summary for 017106
| Tradename: | ATROPEN |
| Applicant: | Mmt |
| Ingredient: | atropine |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 017106
| Mechanism of Action | Cholinergic Antagonists Cholinergic Muscarinic Antagonists |
Medical Subject Heading (MeSH) Categories for 017106
Suppliers and Packaging for NDA: 017106
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ATROPEN | atropine | SOLUTION;INTRAMUSCULAR | 017106 | NDA | Meridian Medical Technologies LLC | 11704-101 | 11704-101-01 | .7 mL in 1 SYRINGE, PLASTIC (11704-101-01) |
| ATROPEN | atropine | SOLUTION;INTRAMUSCULAR | 017106 | NDA | Meridian Medical Technologies LLC | 11704-104 | 11704-104-01 | .7 mL in 1 SYRINGE, PLASTIC (11704-104-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAMUSCULAR | Strength | EQ 2MG SULFATE/0.7ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAMUSCULAR | Strength | EQ 1MG SULFATE/0.7ML | ||||
| Approval Date: | Jun 19, 2003 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAMUSCULAR | Strength | EQ 0.5MG SULFATE/0.7ML | ||||
| Approval Date: | Jun 19, 2003 | TE: | RLD: | Yes | |||||
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