Application 021009

Type: NDA
Sponsor: ALLERGAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ALOCRIL	NEDOCROMIL SODIUM	SOLUTION/DROPS;OPHTHALMIC	2%	Yes	Yes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021009-001	ALOCRIL	NEDOCROMIL SODIUM	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	1999-12-08

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N021009-001	ALOCRIL	2%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1999-12-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021009-001	ALOCRIL	2%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1999-12-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021009-001	ALOCRIL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1999-12-08	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021009-001	ALOCRIL	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	1999-12-08	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021009-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021009-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021009-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021009-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021009-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021009-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021009-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021009-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021009-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021009-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021009-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021009-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021009-001	AT	1	`ea99ee380514…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021009-001	AT	1	`cb3db0bc1861…`

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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0023-8842	ALOCRIL	nedocromil sodium	Allergan, Inc.	NDA	Current
0023-8842	ALOCRIL	nedocromil sodium	Allergan, Inc.	NDA	Current
0023-8842	ALOCRIL	nedocromil sodium	Allergan, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
35878	SUPPL	2008-07-09
26479	SUPPL	2008-07-08
35877	SUPPL	2007-08-22
26477	SUPPL	2007-08-22
14157	SUPPL	2007-08-22
4030	SUPPL	2007-08-22
26478	SUPPL	2004-10-22
4031	SUPPL	2004-10-22
41873	ORIG	2004-05-26
4029	SUPPL	2002-03-08
26476	ORIG	1999-12-08
14156	ORIG	1999-12-08