Application 022055

Type: NDA
Sponsor: ALMIRALL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ALTABAX	RETAPAMULIN	OINTMENT;TOPICAL	1%	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N022055-001	ALTABAX	RETAPAMULIN	1%	OINTMENT / TOPICAL		RLD	2007-04-12

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022055-001	7875630	2027-02-14		Drug substance	2011-02-10

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-09-29 23:25 UTC	2022-09	N022055-001	ALTABAX	1%	OINTMENT / TOPICAL	RLD, RS	2007-04-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022055-001	ALTABAX	1%	OINTMENT / TOPICAL	RLD, RS	2007-04-12	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022055-001	ALTABAX	1%	OINTMENT / TOPICAL	RLD	2007-04-12	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 87 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022055-001	7875630	2027-02-14		Drug substance	2011-02-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022055-001	7875630	2027-02-14		Drug substance	2011-02-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022055-001	7875630	2027-02-14		Drug substance	2011-02-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022055-001	7875630	2027-02-14		Drug substance	2011-02-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022055-001	7875630	2027-02-14		Drug substance	2011-02-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022055-001	7875630	2027-02-14		Drug substance	2011-02-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022055-001	7875630	2027-02-14		Drug substance	2011-02-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022055-001	8207191	2024-08-30	U-805		2016-09-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022055-001	7875630	2027-02-14		Drug substance	2011-02-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022055-001	8207191	2024-08-30	U-805		2016-09-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022055-001	7875630	2027-02-14		Drug substance	2011-02-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022055-001	8207191	2024-08-30	U-805		2016-09-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022055-001	7875630	2027-02-14		Drug substance	2011-02-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022055-001	8207191	2024-08-30	U-805		2016-09-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022055-001	7875630	2027-02-14		Drug substance	2011-02-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022055-001	8207191	2024-08-30	U-805		2016-09-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022055-001	7875630	2027-02-14		Drug substance	2011-02-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022055-001	8207191	2024-08-30	U-805		2016-09-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022055-001	7875630	2027-02-14		Drug substance	2011-02-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022055-001	8207191	2024-08-30	U-805		2016-09-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022055-001	7875630	2027-02-14		Drug substance	2011-02-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022055-001	8207191	2024-08-30	U-805		2016-09-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022055-001	7875630	2027-02-14		Drug substance	2011-02-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022055-001	8207191	2024-08-30	U-805		2016-09-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022055-001	7875630	2027-02-14		Drug substance	2011-02-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022055-001	8207191	2024-08-30	U-805		2016-09-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022055-001	7875630	2027-02-14		Drug substance	2011-02-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022055-001	8207191	2024-08-30	U-805		2016-09-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022055-001	7875630	2027-02-14		Drug substance	2011-02-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022055-001	8207191	2024-08-30	U-805		2016-09-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022055-001	7875630	2027-02-14		Drug substance	2011-02-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022055-001	RE43390	2021-04-12	U-805	Drug substance, Drug product	2012-07-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022055-001	8207191	2024-08-30	U-805		2016-09-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022055-001	7875630	2027-02-14		Drug substance	2011-02-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022055-001	8207191	2024-08-30	U-805		2016-09-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022055-001	7875630	2027-02-14		Drug substance	2011-02-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022055-001	RE43390	2021-04-12	U-805	Drug substance, Drug product	2012-07-09	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022055-001	8207191	2024-08-30	U-805		2016-09-13	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022055-001	7875630	2027-02-14		Drug substance	2011-02-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022055-001	RE43390	2021-04-12	U-805	Drug substance, Drug product	2012-07-09	`87673890dc5c…`

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16110-518	Altabax	retapamulin	Aqua Pharmaceuticals, LLC	NDA	Current
16110-518	Altabax	retapamulin	Almirall, LLC	NDA	Current
16110-518	Altabax	retapamulin	Almirall, LLC	NDA	Current
16110-518	Altabax	retapamulin	Almirall, LLC	NDA	Current
21695-644	Altabax	retapamulin	Rebel Distributors Corp.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
59987	SUPPL	2019-09-12
59981	SUPPL	2019-09-12
38148	SUPPL	2012-12-28
29159	SUPPL	2012-12-27
16850	SUPPL	2010-10-07
29160	SUPPL	2010-10-04
21920	ORIG	2007-05-29
29158	ORIG	2007-04-20
16849	ORIG	2007-04-20
53393	ORIG	1900-01-01
53392	ORIG	1900-01-01