Application 208183

Type: NDA
Sponsor: SUN PHARM INDUSTRIES

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ULTRAVATE	HALOBETASOL PROPIONATE	LOTION;TOPICAL	0.05%	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
N208183-001	ULTRAVATE	HALOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		RLD, RS	2015-11-06

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
N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03

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	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD	2015-11-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD	2015-11-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD	2015-11-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD	2015-11-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD	2015-11-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD	2015-11-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD	2015-11-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD	2015-11-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD	2015-11-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD	2015-11-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 41 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	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`cb3db0bc1861…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208183-001	NPP	2023-08-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208183-001	NPP	2023-08-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208183-001	NPP	2023-08-31	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N208183-001	NPP	2023-08-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208183-001	NPP	2023-08-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208183-001	NPP	2023-08-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208183-001	NPP	2023-08-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208183-001	NPP	2023-08-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208183-001	NPP	2023-08-31	`c0c555d07b60…`
2023-12-20 04:57 UTC	2023-12	N208183-001	NPP	2023-08-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208183-001	NPP	2023-08-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208183-001	NPP	2023-08-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208183-001	NPP	2023-08-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208183-001	NPP	2023-08-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208183-001	NPP	2023-08-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208183-001	NPP	2023-08-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208183-001	NPP	2023-08-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208183-001	NPP	2023-08-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208183-001	NPP	2023-08-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208183-001	NPP	2023-08-31	`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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Halobetasol Propionate	HALOBETASOL PROPIONATE	Coral Way Pharma, LLC	4cb1f7b3-c412-6fc7-e063-6394a90a63c9	2026-06-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208183 application number: NDA208183
ULTRAVATE	HALOBETASOL PROPIONATE	Lacer Pharma, LLC	74e899db-1c1f-48b2-9913-5d32a14906ae	2025-04-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208183 application number: NDA208183

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
10631-122	Ultravate	halobetasol propionate	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-122	Ultravate	halobetasol propionate	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-122	Ultravate	halobetasol propionate	Sun Pharmaceutical Industries, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
64502	SUPPL	2020-09-04
64441	SUPPL	2020-08-28
24535	ORIG	2016-06-29
23052	ORIG	2016-06-29
32896	ORIG	2015-11-13
40622	ORIG	2015-11-12