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FDA NDA · NDA011963

PHOSPHOLINE IODIDE

echothiophate iodide for ophthalmic solution

Sponsor: FERA PHARMS LLC

APPLICATION
NDA011963
TYPE
NDA
ORIGINAL APPROVAL
1960-06-27
LATEST ACTION
2021-10-28
ROUTE
OPHTHALMIC
DOSAGE FORM
FOR SOLUTION
MARKETING STATUS
Discontinued, Prescription

Products

PHOSPHOLINE IODIDEDiscontinued
ECHOTHIOPHATE IODIDE 0.06% · FOR SOLUTION · OPHTHALMIC
PHOSPHOLINE IODIDEDiscontinued
ECHOTHIOPHATE IODIDE 0.03% · FOR SOLUTION · OPHTHALMIC
PHOSPHOLINE IODIDEDiscontinued
ECHOTHIOPHATE IODIDE 0.25% · FOR SOLUTION · OPHTHALMIC
PHOSPHOLINE IODIDE · ReferencePrescription
ECHOTHIOPHATE IODIDE 0.125% · FOR SOLUTION · OPHTHALMIC

Approval history

2021-10-28Labeling · Supplement 52 · standard — Letter ↗AP
2018-07-03Labeling · Supplement 48 · standard — Letter ↗AP
2014-02-28Manufacturing (CMC) · Supplement 47 · standardAP
2006-03-09Labeling · Supplement 34 · standard — Letter ↗AP
2002-04-12Manufacturing (CMC) · Supplement 32 · standardAP
1998-03-10Manufacturing (CMC) · Supplement 31 · standardAP
1995-03-21Manufacturing (CMC) · Supplement 30 · standardAP
1993-05-17Manufacturing (CMC) · Supplement 29 · standardAP
1990-07-13Manufacturing (CMC) · Supplement 28 · standardAP
1990-01-09Manufacturing (CMC) · Supplement 27 · standardAP
1989-08-01Manufacturing (CMC) · Supplement 26 · standardAP
1988-11-29Manufacturing (CMC) · Supplement 25 · standardAP
1987-05-11Labeling · Supplement 23AP
1984-10-30Manufacturing (CMC) · Supplement 24 · standardAP
1982-06-10Manufacturing (CMC) · Supplement 21 · standardAP
1982-05-26Manufacturing (CMC) · Supplement 22 · standardAP
1981-12-28Manufacturing (CMC) · Supplement 20 · standardAP
1981-11-25Manufacturing (CMC) · Supplement 19 · standardAP
1981-05-19Manufacturing (CMC) · Supplement 18 · standardAP
1980-01-02Manufacturing (CMC) · Supplement 16 · standardAP
1979-08-01Labeling · Supplement 17AP
1978-08-09Labeling · Supplement 15AP
1978-08-09Manufacturing (CMC) · Supplement 13 · standardAP
1978-08-09Manufacturing (CMC) · Supplement 14 · standardAP
1976-10-13Supplement · Supplement 12 · standardAP
1960-06-27Type 1 - New Molecular Entity · Original · standardAP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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