Details for New Drug Application (NDA): 219013
NDA 219013 describes ATROPINE SULFATE, which is a drug marketed by Us Army, Amneal, Apotex, Bausch And Lomb Inc, Edenbridge Pharms, Gland, Mankind Pharma, Rising, Somerset, Somerset Theraps Llc, Accord Hlthcare, Am Regent, Hikma, Hospira, Intl Medication Sys, Medefil Inc, and Fresenius Kabi Usa, and is included in twenty-three NDAs. It is available from twenty-six suppliers. Additional details are available on the ATROPINE SULFATE profile page.
The generic ingredient in ATROPINE SULFATE is atropine sulfate. There is one drug master file entry for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the atropine sulfate profile page.
The generic ingredient in ATROPINE SULFATE is atropine sulfate. There is one drug master file entry for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the atropine sulfate profile page.
Summary for 219013
| Tradename: | ATROPINE SULFATE |
| Applicant: | Edenbridge Pharms |
| Ingredient: | atropine sulfate |
| Patents: | 0 |
Pharmacology for NDA: 219013
| Mechanism of Action | Cholinergic Antagonists Cholinergic Muscarinic Antagonists |
Suppliers and Packaging for NDA: 219013
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ATROPINE SULFATE | atropine sulfate | SOLUTION/DROPS;OPHTHALMIC | 219013 | ANDA | Edenbridge Pharmaceuticals LLC. | 42799-826 | 42799-826-01 | 1 BOTTLE in 1 CARTON (42799-826-01) / 2 mL in 1 BOTTLE |
| ATROPINE SULFATE | atropine sulfate | SOLUTION/DROPS;OPHTHALMIC | 219013 | ANDA | Edenbridge Pharmaceuticals LLC. | 42799-826 | 42799-826-02 | 1 BOTTLE in 1 CARTON (42799-826-02) / 5 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 1% | ||||
| Approval Date: | Apr 15, 2026 | TE: | AT1 | RLD: | No | ||||
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