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Details for New Drug Application (NDA): 011963

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NDA 011963 describes PHOSPHOLINE IODIDE, which is a drug marketed by Wyeth Pharms Inc 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 NDA: 011963

Wyeth Pharms Inc
echothiophate iodide
Therapeutic Class:Ophthalmic Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 011963

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
echothiophate iodide
FOR SOLUTION;OPHTHALMIC 011963 NDA Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. 0046-1065 0046-1065-05 1 KIT in 1 KIT (0046-1065-05) * 6.25 mL in 1 BOTTLE (0046-1465-05) * 5 mL in 1 BOTTLE (0046-1162-05)

Summary for product number 001

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

Summary for product number 002

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

Summary 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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