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Last Updated: April 24, 2024

Details for New Drug Application (NDA): 011963

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NDA 011963 describes PHOSPHOLINE IODIDE, which is a drug marketed by Fera Pharms Llc and is included in one NDA. It is available from one supplier. Additional details are available on the PHOSPHOLINE IODIDE profile page.

The generic ingredient in PHOSPHOLINE IODIDE is echothiophate iodide. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the echothiophate iodide profile page.
Summary for 011963
Applicant:Fera Pharms Llc
Ingredient:echothiophate iodide
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 011963
Suppliers and Packaging for NDA: 011963
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PHOSPHOLINE IODIDE echothiophate iodide FOR SOLUTION;OPHTHALMIC 011963 NDA Fera Pharmaceuticals, LLC 48102-053 48102-053-05 1 KIT in 1 CARTON (48102-053-05) * 6.25 mL in 1 BOTTLE (48102-054-05) * 5 mL in 1 BOTTLE (48102-055-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SOLUTION;OPHTHALMICStrength0.125%
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:FOR SOLUTION;OPHTHALMICStrength0.03%
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:FOR SOLUTION;OPHTHALMICStrength0.25%
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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