Application 020922

Type: NDA
Sponsor: ALMIRALL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SOLAGE	MEQUINOL; TRETINOIN	SOLUTION;TOPICAL	2%;0.01%	No	No

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
N020922-001	SOLAGE	MEQUINOL; TRETINOIN	2%;0.01%	SOLUTION / TOPICAL			1999-12-10

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	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N020922-001	SOLAGE	2%;0.01%	SOLUTION / TOPICAL	1999-12-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020922-001	SOLAGE	2%;0.01%	SOLUTION / TOPICAL	1999-12-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020922-001	SOLAGE	2%;0.01%	SOLUTION / TOPICAL	1999-12-10	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020922-001	SOLAGE	2%;0.01%	SOLUTION / TOPICAL	1999-12-10	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020922-001	6353029	2020-08-24	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N020922-001	6353029	2020-08-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020922-001	6353029	2020-08-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020922-001	6353029	2020-08-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020922-001	6353029	2020-08-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020922-001	6353029	2020-08-24	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
61153	SUPPL	2019-12-04
61126	SUPPL	2019-12-03
3760	SUPPL	2010-01-05
13748	SUPPL	2010-01-04
26206	SUPPL	2007-05-01
13747	SUPPL	2007-05-01
21277	ORIG	2002-04-10
13746	ORIG	1999-12-10
3759	ORIG	1999-12-10