Details for New Drug Application (NDA): 217791
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NDA 217791 describes ATROPINE SULFATE, which is a drug marketed by Us Army, Amneal, Apotex, Bausch And Lomb Inc, Mankind Pharma, Rising, Somerset, Somerset Theraps Llc, Accord Hlthcare, Am Regent, Hospira, Intl Medication Sys, Medefil Inc, Fresenius Kabi Usa, and Hikma, and is included in nineteen NDAs. It is available from twenty-two suppliers. Additional details are available on the ATROPINE SULFATE profile page.
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.
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 217791
| Tradename: | ATROPINE SULFATE |
| Applicant: | Somerset |
| Ingredient: | atropine sulfate |
| Patents: | 0 |
Pharmacology for NDA: 217791
| Mechanism of Action | Cholinergic Antagonists Cholinergic Muscarinic Antagonists |
Suppliers and Packaging for NDA: 217791
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ATROPINE SULFATE | atropine sulfate | SOLUTION/DROPS;OPHTHALMIC | 217791 | ANDA | Somerset Therapeutics, LLC | 70069-716 | 70069-716-01 | 1 BOTTLE in 1 CARTON (70069-716-01) / 5 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 1% | ||||
| Approval Date: | Apr 29, 2024 | TE: | AT2 | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Dec 4, 2024 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
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