Application 202428

Type: NDA
Sponsor: MAYNE PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FABIOR	TAZAROTENE	AEROSOL, FOAM;TOPICAL	0.1%	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
N202428-001	FABIOR	TAZAROTENE	0.1%	AEROSOL, FOAM / TOPICAL		RLD, RS	2012-05-11

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N202428-001	10568859	2030-02-24	U-2760	Drug product	2020-03-25
N202428-001	10688071	2030-02-24	U-2760	Drug product	2020-07-08
N202428-001	8808716	2030-02-24		Drug product	2014-08-20

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N202428-001	FABIOR	0.1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2012-05-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202428-001	FABIOR	0.1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2012-05-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202428-001	FABIOR	0.1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2012-05-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202428-001	FABIOR	0.1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2012-05-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202428-001	FABIOR	0.1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2012-05-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202428-001	FABIOR	0.1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2012-05-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202428-001	FABIOR	0.1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2012-05-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202428-001	FABIOR	0.1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2012-05-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202428-001	FABIOR	0.1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2012-05-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202428-001	FABIOR	0.1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2012-05-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202428-001	FABIOR	0.1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2012-05-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202428-001	FABIOR	0.1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2012-05-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202428-001	FABIOR	0.1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2012-05-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202428-001	FABIOR	0.1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2012-05-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202428-001	FABIOR	0.1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2012-05-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202428-001	FABIOR	0.1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2012-05-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202428-001	FABIOR	0.1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2012-05-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N202428-001	FABIOR	0.1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2012-05-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N202428-001	FABIOR	0.1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2012-05-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N202428-001	FABIOR	0.1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2012-05-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202428-001	FABIOR	0.1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2012-05-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N202428-001	FABIOR	0.1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2012-05-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N202428-001	FABIOR	0.1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2012-05-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N202428-001	FABIOR	0.1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2012-05-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N202428-001	FABIOR	0.1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2012-05-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N202428-001	FABIOR	0.1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2012-05-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N202428-001	FABIOR	0.1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2012-05-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N202428-001	FABIOR	0.1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2012-05-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N202428-001	FABIOR	0.1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2012-05-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N202428-001	FABIOR	0.1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2012-05-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N202428-001	FABIOR	0.1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2012-05-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N202428-001	FABIOR	0.1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2012-05-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N202428-001	FABIOR	0.1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2012-05-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N202428-001	FABIOR	0.1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2012-05-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N202428-001	FABIOR	0.1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2012-05-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N202428-001	FABIOR	0.1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2012-05-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N202428-001	FABIOR	0.1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2012-05-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N202428-001	FABIOR	0.1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2012-05-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N202428-001	FABIOR	0.1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2012-05-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N202428-001	FABIOR	0.1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2012-05-11	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 115 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N202428-001	10568859	2030-02-24	U-2760	Drug product	2020-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202428-001	10688071	2030-02-24	U-2760	Drug product	2020-07-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202428-001	8808716	2030-02-24		Drug product	2014-08-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202428-001	10568859	2030-02-24	U-2760	Drug product	2020-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202428-001	10688071	2030-02-24	U-2760	Drug product	2020-07-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202428-001	8808716	2030-02-24		Drug product	2014-08-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202428-001	10568859	2030-02-24	U-2760	Drug product	2020-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202428-001	10688071	2030-02-24	U-2760	Drug product	2020-07-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202428-001	8808716	2030-02-24		Drug product	2014-08-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202428-001	10568859	2030-02-24	U-2760	Drug product	2020-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202428-001	10688071	2030-02-24	U-2760	Drug product	2020-07-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202428-001	8808716	2030-02-24		Drug product	2014-08-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202428-001	10568859	2030-02-24	U-2760	Drug product	2020-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202428-001	10688071	2030-02-24	U-2760	Drug product	2020-07-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202428-001	8808716	2030-02-24		Drug product	2014-08-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202428-001	10568859	2030-02-24	U-2760	Drug product	2020-03-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202428-001	10688071	2030-02-24	U-2760	Drug product	2020-07-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202428-001	8808716	2030-02-24		Drug product	2014-08-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202428-001	10568859	2030-02-24	U-2760	Drug product	2020-03-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202428-001	10688071	2030-02-24	U-2760	Drug product	2020-07-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202428-001	8808716	2030-02-24		Drug product	2014-08-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202428-001	10568859	2030-02-24	U-2760	Drug product	2020-03-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202428-001	10688071	2030-02-24	U-2760	Drug product	2020-07-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202428-001	8808716	2030-02-24		Drug product	2014-08-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202428-001	10568859	2030-02-24	U-2760	Drug product	2020-03-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202428-001	10688071	2030-02-24	U-2760	Drug product	2020-07-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202428-001	8808716	2030-02-24		Drug product	2014-08-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202428-001	10568859	2030-02-24	U-2760	Drug product	2020-03-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202428-001	10688071	2030-02-24	U-2760	Drug product	2020-07-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202428-001	8808716	2030-02-24		Drug product	2014-08-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202428-001	10568859	2030-02-24	U-2760	Drug product	2020-03-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202428-001	10688071	2030-02-24	U-2760	Drug product	2020-07-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202428-001	8808716	2030-02-24		Drug product	2014-08-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202428-001	10568859	2030-02-24	U-2760	Drug product	2020-03-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202428-001	10688071	2030-02-24	U-2760	Drug product	2020-07-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202428-001	8808716	2030-02-24		Drug product	2014-08-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202428-001	10568859	2030-02-24	U-2760	Drug product	2020-03-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202428-001	10688071	2030-02-24	U-2760	Drug product	2020-07-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202428-001	8808716	2030-02-24		Drug product	2014-08-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202428-001	10568859	2030-02-24	U-2760	Drug product	2020-03-25	`8072bd15b7f6…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FABIOR	TAZAROTENE	Mayne Pharma	ae0afed7-1d60-45fd-a08b-8db094618521	2026-03-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 202428 application number: NDA202428 ndc (product): 51862-295
tazarotene	TAZAROTENE	Mayne Pharma Inc.	0e337598-f589-483f-a2ae-be7c319d7454	2024-06-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 202428 application number: NDA202428 ndc (product): 68308-685

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
51862-295	FABIOR	tazarotene	Mayne Pharma	NDA	Current
51862-295	FABIOR	tazarotene	Mayne Pharma	NDA	Current
68308-685	tazarotene	tazarotene	Mayne Pharma Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44857	ORIG	2012-11-05
22889	ORIG	2012-11-05
10044	ORIG	2012-05-16
40179	ORIG	2012-05-15