Application 206716

Type: ANDA
Sponsor: NOVAST LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MAFENIDE ACETATE	MAFENIDE ACETATE	FOR SOLUTION;TOPICAL	5%	No	No

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
A206716-001	MAFENIDE ACETATE	MAFENIDE ACETATE	5%	FOR SOLUTION / TOPICAL			2017-07-31

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	A206716-001	MAFENIDE ACETATE	5%	FOR SOLUTION / TOPICAL			2017-07-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206716-001	MAFENIDE ACETATE	5%	FOR SOLUTION / TOPICAL			2017-07-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206716-001	MAFENIDE ACETATE	5%	FOR SOLUTION / TOPICAL			2017-07-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206716-001	MAFENIDE ACETATE	5%	FOR SOLUTION / TOPICAL			2017-07-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206716-001	MAFENIDE ACETATE	5%	FOR SOLUTION / TOPICAL			2017-07-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206716-001	MAFENIDE ACETATE	5%	FOR SOLUTION / TOPICAL			2017-07-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206716-001	MAFENIDE ACETATE	5%	FOR SOLUTION / TOPICAL			2017-07-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206716-001	MAFENIDE ACETATE	5%	FOR SOLUTION / TOPICAL			2017-07-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206716-001	MAFENIDE ACETATE	5%	FOR SOLUTION / TOPICAL			2017-07-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206716-001	MAFENIDE ACETATE	5%	FOR SOLUTION / TOPICAL			2017-07-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206716-001	MAFENIDE ACETATE	5%	FOR SOLUTION / TOPICAL			2017-07-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206716-001	MAFENIDE ACETATE	5%	FOR SOLUTION / TOPICAL			2017-07-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206716-001	MAFENIDE ACETATE	5%	FOR SOLUTION / TOPICAL			2017-07-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206716-001	MAFENIDE ACETATE	5%	FOR SOLUTION / TOPICAL			2017-07-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206716-001	MAFENIDE ACETATE	5%	FOR SOLUTION / TOPICAL	AT		2017-07-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206716-001	MAFENIDE ACETATE	5%	FOR SOLUTION / TOPICAL	AT		2017-07-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206716-001	MAFENIDE ACETATE	5%	FOR SOLUTION / TOPICAL	AT		2017-07-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206716-001	MAFENIDE ACETATE	5%	FOR SOLUTION / TOPICAL	AT		2017-07-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206716-001	MAFENIDE ACETATE	5%	FOR SOLUTION / TOPICAL	AT		2017-07-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206716-001	MAFENIDE ACETATE	5%	FOR SOLUTION / TOPICAL	AT		2017-07-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206716-001	MAFENIDE ACETATE	5%	FOR SOLUTION / TOPICAL	AT		2017-07-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206716-001	MAFENIDE ACETATE	5%	FOR SOLUTION / TOPICAL	AT		2017-07-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206716-001	MAFENIDE ACETATE	5%	FOR SOLUTION / TOPICAL	AT		2017-07-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206716-001	MAFENIDE ACETATE	5%	FOR SOLUTION / TOPICAL	AT		2017-07-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206716-001	MAFENIDE ACETATE	5%	FOR SOLUTION / TOPICAL	AT		2017-07-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206716-001	MAFENIDE ACETATE	5%	FOR SOLUTION / TOPICAL	AT		2017-07-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206716-001	MAFENIDE ACETATE	5%	FOR SOLUTION / TOPICAL	AT		2017-07-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206716-001	MAFENIDE ACETATE	5%	FOR SOLUTION / TOPICAL			2017-07-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206716-001	MAFENIDE ACETATE	5%	FOR SOLUTION / TOPICAL			2017-07-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206716-001	MAFENIDE ACETATE	5%	FOR SOLUTION / TOPICAL			2017-07-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206716-001	MAFENIDE ACETATE	5%	FOR SOLUTION / TOPICAL			2017-07-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206716-001	MAFENIDE ACETATE	5%	FOR SOLUTION / TOPICAL			2017-07-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206716-001	MAFENIDE ACETATE	5%	FOR SOLUTION / TOPICAL			2017-07-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206716-001	MAFENIDE ACETATE	5%	FOR SOLUTION / TOPICAL			2017-07-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206716-001	MAFENIDE ACETATE	5%	FOR SOLUTION / TOPICAL		RS	2017-07-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206716-001	MAFENIDE ACETATE	5%	FOR SOLUTION / TOPICAL		RS	2017-07-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206716-001	MAFENIDE ACETATE	5%	FOR SOLUTION / TOPICAL	AT		2017-07-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206716-001	MAFENIDE ACETATE	5%	FOR SOLUTION / TOPICAL	AT		2017-07-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206716-001	MAFENIDE ACETATE	5%	FOR SOLUTION / TOPICAL	AT		2017-07-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206716-001	MAFENIDE ACETATE	5%	FOR SOLUTION / TOPICAL	AT		2017-07-31	`cb3db0bc1861…`

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	A206716-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206716-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206716-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206716-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206716-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206716-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206716-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206716-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206716-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206716-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206716-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206716-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206716-001	AT	1	`ea99ee380514…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206716-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206716-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206716-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206716-001	AT	1	`cb3db0bc1861…`

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 generic name: MAFENIDE ACETATE

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50742-310	Mafenide Acetate	Mafenide Acetate	Ingenus Pharmaceuticals, LLC	ANDA	Current