Application 019832

Type: NDA
Sponsor: MYLAN INSTITUTIONAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
003	SULFAMYLON	MAFENIDE ACETATE	FOR SOLUTION;TOPICAL	5%	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N019832-003	SULFAMYLON	MAFENIDE ACETATE	5%	FOR SOLUTION / TOPICAL		RLD	1998-06-05

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 1 of 2 · 41 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
2026-02-19 14:30 UTC	2026-02	N019832-003	SULFAMYLON	5%	FOR SOLUTION / TOPICAL		RLD	1998-06-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019832-003	SULFAMYLON	5%	FOR SOLUTION / TOPICAL		RLD	1998-06-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019832-003	SULFAMYLON	5%	FOR SOLUTION / TOPICAL		RLD	1998-06-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019832-003	SULFAMYLON	5%	FOR SOLUTION / TOPICAL		RLD	1998-06-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019832-003	SULFAMYLON	5%	FOR SOLUTION / TOPICAL		RLD	1998-06-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019832-003	SULFAMYLON	5%	FOR SOLUTION / TOPICAL		RLD	1998-06-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019832-003	SULFAMYLON	5%	FOR SOLUTION / TOPICAL		RLD	1998-06-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019832-003	SULFAMYLON	5%	FOR SOLUTION / TOPICAL		RLD	1998-06-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019832-003	SULFAMYLON	5%	FOR SOLUTION / TOPICAL		RLD	1998-06-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019832-003	SULFAMYLON	5%	FOR SOLUTION / TOPICAL		RLD	1998-06-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019832-003	SULFAMYLON	5%	FOR SOLUTION / TOPICAL		RLD	1998-06-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019832-003	SULFAMYLON	5%	FOR SOLUTION / TOPICAL		RLD	1998-06-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019832-003	SULFAMYLON	5%	FOR SOLUTION / TOPICAL		RLD	1998-06-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019832-003	SULFAMYLON	5%	FOR SOLUTION / TOPICAL		RLD	1998-06-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019832-003	SULFAMYLON	5%	FOR SOLUTION / TOPICAL		RLD	1998-06-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019832-003	SULFAMYLON	5%	FOR SOLUTION / TOPICAL		RLD	1998-06-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019832-003	SULFAMYLON	5%	FOR SOLUTION / TOPICAL		RLD	1998-06-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019832-003	SULFAMYLON	5%	FOR SOLUTION / TOPICAL	AT	RLD, RS	1998-06-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019832-003	SULFAMYLON	5%	FOR SOLUTION / TOPICAL	AT	RLD, RS	1998-06-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019832-003	SULFAMYLON	5%	FOR SOLUTION / TOPICAL	AT	RLD, RS	1998-06-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019832-003	SULFAMYLON	5%	FOR SOLUTION / TOPICAL	AT	RLD, RS	1998-06-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019832-003	SULFAMYLON	5%	FOR SOLUTION / TOPICAL	AT	RLD, RS	1998-06-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019832-003	SULFAMYLON	5%	FOR SOLUTION / TOPICAL	AT	RLD, RS	1998-06-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019832-003	SULFAMYLON	5%	FOR SOLUTION / TOPICAL	AT	RLD, RS	1998-06-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019832-003	SULFAMYLON	5%	FOR SOLUTION / TOPICAL	AT	RLD, RS	1998-06-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019832-003	SULFAMYLON	5%	FOR SOLUTION / TOPICAL	AT	RLD, RS	1998-06-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019832-003	SULFAMYLON	5%	FOR SOLUTION / TOPICAL	AT	RLD, RS	1998-06-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019832-003	SULFAMYLON	5%	FOR SOLUTION / TOPICAL		RLD	1998-06-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019832-003	SULFAMYLON	5%	FOR SOLUTION / TOPICAL		RLD	1998-06-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019832-003	SULFAMYLON	5%	FOR SOLUTION / TOPICAL		RLD	1998-06-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019832-003	SULFAMYLON	5%	FOR SOLUTION / TOPICAL		RLD	1998-06-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019832-003	SULFAMYLON	5%	FOR SOLUTION / TOPICAL		RLD	1998-06-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019832-003	SULFAMYLON	5%	FOR SOLUTION / TOPICAL		RLD	1998-06-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019832-003	SULFAMYLON	5%	FOR SOLUTION / TOPICAL		RLD	1998-06-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019832-003	SULFAMYLON	5%	FOR SOLUTION / TOPICAL		RLD	1998-06-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019832-003	SULFAMYLON	5%	FOR SOLUTION / TOPICAL		RLD	1998-06-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019832-003	SULFAMYLON	5%	FOR SOLUTION / TOPICAL		RLD	1998-06-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019832-003	SULFAMYLON	5%	FOR SOLUTION / TOPICAL		RLD	1998-06-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019832-003	SULFAMYLON	5%	FOR SOLUTION / TOPICAL		RLD	1998-06-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019832-003	SULFAMYLON	5%	FOR SOLUTION / TOPICAL		RLD	1998-06-05	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N019832-003	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019832-003	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019832-003	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019832-003	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019832-003	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019832-003	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019832-003	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019832-003	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019832-003	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019832-003	AT	1	`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
SULFAMYLON	MAFENIDE ACETATE	Rising Pharma Holdings, Inc.	008eaa23-8f19-4e39-85ff-540c1c834a9e	2023-07-03	Warnings, Adverse reactions	Name fallback brand name: SULFAMYLON generic name: MAFENIDE ACETATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51079-624	Sulfamylon	mafenide acetate	Mylan Institutional Inc.	NDA	Current
51079-624	Sulfamylon	mafenide acetate	Mylan Institutional Inc.	NDA	Current
51079-624	Sulfamylon	mafenide acetate	Mylan Institutional Inc.	NDA	Current
51079-624	Sulfamylon	mafenide acetate	Mylan Institutional Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
19273	SUPPL	2001-07-12
19272	SUPPL	2001-07-12
41045	ORIG	1999-01-06
33997	ORIG	1998-06-05
1659	ORIG	1998-06-05