Details for New Drug Application (NDA): 215618
✉ Email this page to a colleague
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 215618
Tradename: | ATROPINE SULFATE |
Applicant: | Somerset Theraps Llc |
Ingredient: | atropine sulfate |
Patents: | 0 |
Pharmacology for NDA: 215618
Mechanism of Action | Cholinergic Antagonists Cholinergic Muscarinic Antagonists |
Suppliers and Packaging for NDA: 215618
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ATROPINE SULFATE | atropine sulfate | SOLUTION/DROPS;OPHTHALMIC | 215618 | ANDA | Somerset Therapeutics, LLC | 70069-581 | 70069-581-01 | 1 BOTTLE in 1 CARTON (70069-581-01) / 2 mL in 1 BOTTLE |
ATROPINE SULFATE | atropine sulfate | SOLUTION/DROPS;OPHTHALMIC | 215618 | ANDA | Somerset Therapeutics, LLC | 70069-582 | 70069-582-01 | 1 BOTTLE in 1 CARTON (70069-582-01) / 5 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 1% | ||||
Approval Date: | Jul 1, 2024 | TE: | AT1 | RLD: | No |
Complete Access Available with Subscription