Application 011963

Type: NDA
Sponsor: WYETH PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PHOSPHOLINE IODIDE	ECHOTHIOPHATE IODIDE	FOR SOLUTION;OPHTHALMIC	0.125%	Yes	Yes
002	PHOSPHOLINE IODIDE	ECHOTHIOPHATE IODIDE	FOR SOLUTION;OPHTHALMIC	0.03%	No	No
003	PHOSPHOLINE IODIDE	ECHOTHIOPHATE IODIDE	FOR SOLUTION;OPHTHALMIC	0.25%	No	No
004	PHOSPHOLINE IODIDE	ECHOTHIOPHATE IODIDE	FOR SOLUTION;OPHTHALMIC	0.06%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS
N011963-001	PHOSPHOLINE IODIDE	ECHOTHIOPHATE IODIDE	0.125%	FOR SOLUTION / OPHTHALMIC	RLD, RS, Approved before 1982
N011963-002	PHOSPHOLINE IODIDE	ECHOTHIOPHATE IODIDE	0.03%	FOR SOLUTION / OPHTHALMIC	Approved before 1982
N011963-003	PHOSPHOLINE IODIDE	ECHOTHIOPHATE IODIDE	0.25%	FOR SOLUTION / OPHTHALMIC	Approved before 1982
N011963-004	PHOSPHOLINE IODIDE	ECHOTHIOPHATE IODIDE	0.06%	FOR SOLUTION / OPHTHALMIC	Approved before 1982

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 3 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N011963-001	PHOSPHOLINE IODIDE	0.125%	FOR SOLUTION / OPHTHALMIC	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N011963-002	PHOSPHOLINE IODIDE	0.03%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N011963-003	PHOSPHOLINE IODIDE	0.25%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N011963-004	PHOSPHOLINE IODIDE	0.06%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N011963-001	PHOSPHOLINE IODIDE	0.125%	FOR SOLUTION / OPHTHALMIC	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N011963-002	PHOSPHOLINE IODIDE	0.03%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N011963-003	PHOSPHOLINE IODIDE	0.25%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N011963-004	PHOSPHOLINE IODIDE	0.06%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N011963-001	PHOSPHOLINE IODIDE	0.125%	FOR SOLUTION / OPHTHALMIC	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N011963-002	PHOSPHOLINE IODIDE	0.03%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N011963-003	PHOSPHOLINE IODIDE	0.25%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N011963-004	PHOSPHOLINE IODIDE	0.06%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N011963-001	PHOSPHOLINE IODIDE	0.125%	FOR SOLUTION / OPHTHALMIC	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N011963-002	PHOSPHOLINE IODIDE	0.03%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N011963-003	PHOSPHOLINE IODIDE	0.25%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N011963-004	PHOSPHOLINE IODIDE	0.06%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N011963-001	PHOSPHOLINE IODIDE	0.125%	FOR SOLUTION / OPHTHALMIC	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N011963-002	PHOSPHOLINE IODIDE	0.03%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N011963-003	PHOSPHOLINE IODIDE	0.25%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N011963-004	PHOSPHOLINE IODIDE	0.06%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N011963-001	PHOSPHOLINE IODIDE	0.125%	FOR SOLUTION / OPHTHALMIC	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N011963-002	PHOSPHOLINE IODIDE	0.03%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N011963-003	PHOSPHOLINE IODIDE	0.25%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N011963-004	PHOSPHOLINE IODIDE	0.06%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N011963-001	PHOSPHOLINE IODIDE	0.125%	FOR SOLUTION / OPHTHALMIC	RLD, RS, Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N011963-002	PHOSPHOLINE IODIDE	0.03%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N011963-003	PHOSPHOLINE IODIDE	0.25%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N011963-004	PHOSPHOLINE IODIDE	0.06%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N011963-001	PHOSPHOLINE IODIDE	0.125%	FOR SOLUTION / OPHTHALMIC	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N011963-002	PHOSPHOLINE IODIDE	0.03%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N011963-003	PHOSPHOLINE IODIDE	0.25%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N011963-004	PHOSPHOLINE IODIDE	0.06%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N011963-001	PHOSPHOLINE IODIDE	0.125%	FOR SOLUTION / OPHTHALMIC	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N011963-002	PHOSPHOLINE IODIDE	0.03%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N011963-003	PHOSPHOLINE IODIDE	0.25%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N011963-004	PHOSPHOLINE IODIDE	0.06%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N011963-001	PHOSPHOLINE IODIDE	0.125%	FOR SOLUTION / OPHTHALMIC	RLD, RS, Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N011963-002	PHOSPHOLINE IODIDE	0.03%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N011963-003	PHOSPHOLINE IODIDE	0.25%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N011963-004	PHOSPHOLINE IODIDE	0.06%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`ea99ee380514…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Phospholine Iodide	ECHOTHIOPHATE IODIDE FOR OPHTHALMIC SOLUTION	Fera Pharmaceuticals, LLC	8afc8951-db76-4f27-8752-7c0d6aa47244	2025-07-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011963 application number: NDA011963 ndc (product): 48102-053

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0046-1065	Phospholine Iodide	echothiophate iodide	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0046-1065	Phospholine Iodide	echothiophate iodide	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0046-1065	Phospholine Iodide	echothiophate iodide	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0046-1065	Phospholine Iodide	echothiophate iodide	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0046-1065	Phospholine Iodide	echothiophate iodide	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0046-1065	Phospholine Iodide	echothiophate iodide	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
48102-053	Phospholine Iodide	echothiophate iodide for ophthalmic solution	Fera Pharmaceuticals, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
69164	SUPPL	2021-11-01
69168	SUPPL	2021-10-29
54779	SUPPL	2018-07-06
295	SUPPL	2006-03-23
10789	SUPPL	2006-03-14