Details for New Drug Application (NDA): 011963

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

Tradename:	PHOSPHOLINE IODIDE
Applicant:	Fera Pharms Llc
Ingredient:	echothiophate iodide
Patents:	0

Medical Subject Heading (MeSH) Categories for 011963

Cholinesterase Inhibitors

Miotics

Parasympathomimetics

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:	RX	Dosage:	FOR SOLUTION;OPHTHALMIC			Strength	0.125%
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FOR SOLUTION;OPHTHALMIC			Strength	0.03%
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FOR SOLUTION;OPHTHALMIC			Strength	0.25%
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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