Details for New Drug Application (NDA): 208151
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NDA 208151 describes ISOPTO ATROPINE, which is a drug marketed by Alcon Labs Inc and is included in one NDA. It is available from one supplier. Additional details are available on the ISOPTO ATROPINE profile page.
The generic ingredient in ISOPTO ATROPINE 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.
The generic ingredient in ISOPTO ATROPINE 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 208151
| Tradename: | ISOPTO ATROPINE |
| Applicant: | Alcon Labs Inc |
| Ingredient: | atropine sulfate |
| Patents: | 0 |
Pharmacology for NDA: 208151
| Mechanism of Action | Cholinergic Antagonists Cholinergic Muscarinic Antagonists |
Suppliers and Packaging for NDA: 208151
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ISOPTO ATROPINE | atropine sulfate | SOLUTION/DROPS;OPHTHALMIC | 208151 | NDA | Alcon Laboratories, Inc. | 0065-0817 | 0065-0817-01 | 1 BOTTLE, DROPPER in 1 CARTON (0065-0817-01) / 5 mL in 1 BOTTLE, DROPPER |
| ISOPTO ATROPINE | atropine sulfate | SOLUTION/DROPS;OPHTHALMIC | 208151 | NDA | Alcon Laboratories, Inc. | 0065-0817 | 0065-0817-02 | 1 BOTTLE, DROPPER in 1 CARTON (0065-0817-02) / 2 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 1% | ||||
| Approval Date: | Dec 1, 2016 | TE: | AT2 | RLD: | Yes | ||||
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