Application 205410

Type: NDA
Sponsor: PIERRE FABRE DERMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HEMANGEOL	PROPRANOLOL HYDROCHLORIDE	SOLUTION;ORAL	4.28MG/ML	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
N205410-001	HEMANGEOL	PROPRANOLOL HYDROCHLORIDE	4.28MG/ML	SOLUTION / ORAL		RLD, RS	2014-03-14

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N205410-001	8338489	2028-10-16	U-1496		2014-03-28
N205410-001	8987262	2028-10-16	U-1988		2017-04-14

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	N205410-001	HEMANGEOL	4.28MG/ML	SOLUTION / ORAL	RLD, RS	2014-03-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205410-001	HEMANGEOL	4.28MG/ML	SOLUTION / ORAL	RLD, RS	2014-03-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205410-001	HEMANGEOL	4.28MG/ML	SOLUTION / ORAL	RLD, RS	2014-03-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205410-001	HEMANGEOL	4.28MG/ML	SOLUTION / ORAL	RLD, RS	2014-03-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205410-001	HEMANGEOL	4.28MG/ML	SOLUTION / ORAL	RLD, RS	2014-03-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205410-001	HEMANGEOL	4.28MG/ML	SOLUTION / ORAL	RLD, RS	2014-03-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205410-001	HEMANGEOL	4.28MG/ML	SOLUTION / ORAL	RLD, RS	2014-03-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205410-001	HEMANGEOL	4.28MG/ML	SOLUTION / ORAL	RLD, RS	2014-03-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205410-001	HEMANGEOL	4.28MG/ML	SOLUTION / ORAL	RLD, RS	2014-03-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205410-001	HEMANGEOL	4.28MG/ML	SOLUTION / ORAL	RLD, RS	2014-03-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205410-001	HEMANGEOL	4.28MG/ML	SOLUTION / ORAL	RLD, RS	2014-03-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205410-001	HEMANGEOL	4.28MG/ML	SOLUTION / ORAL	RLD, RS	2014-03-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205410-001	HEMANGEOL	4.28MG/ML	SOLUTION / ORAL	RLD, RS	2014-03-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205410-001	HEMANGEOL	4.28MG/ML	SOLUTION / ORAL	RLD, RS	2014-03-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205410-001	HEMANGEOL	4.28MG/ML	SOLUTION / ORAL	RLD, RS	2014-03-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205410-001	HEMANGEOL	4.28MG/ML	SOLUTION / ORAL	RLD, RS	2014-03-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205410-001	HEMANGEOL	4.28MG/ML	SOLUTION / ORAL	RLD, RS	2014-03-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205410-001	HEMANGEOL	4.28MG/ML	SOLUTION / ORAL	RLD, RS	2014-03-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N205410-001	HEMANGEOL	4.28MG/ML	SOLUTION / ORAL	RLD, RS	2014-03-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205410-001	HEMANGEOL	4.28MG/ML	SOLUTION / ORAL	RLD, RS	2014-03-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205410-001	HEMANGEOL	4.28MG/ML	SOLUTION / ORAL	RLD, RS	2014-03-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205410-001	HEMANGEOL	4.28MG/ML	SOLUTION / ORAL	RLD, RS	2014-03-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N205410-001	HEMANGEOL	4.28MG/ML	SOLUTION / ORAL	RLD, RS	2014-03-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205410-001	HEMANGEOL	4.28MG/ML	SOLUTION / ORAL	RLD, RS	2014-03-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205410-001	HEMANGEOL	4.28MG/ML	SOLUTION / ORAL	RLD, RS	2014-03-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205410-001	HEMANGEOL	4.28MG/ML	SOLUTION / ORAL	RLD, RS	2014-03-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205410-001	HEMANGEOL	4.28MG/ML	SOLUTION / ORAL	RLD, RS	2014-03-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N205410-001	HEMANGEOL	4.28MG/ML	SOLUTION / ORAL	RLD, RS	2014-03-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N205410-001	HEMANGEOL	4.28MG/ML	SOLUTION / ORAL	RLD, RS	2014-03-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N205410-001	HEMANGEOL	4.28MG/ML	SOLUTION / ORAL	RLD, RS	2014-03-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N205410-001	HEMANGEOL	4.28MG/ML	SOLUTION / ORAL	RLD, RS	2014-03-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N205410-001	HEMANGEOL	4.28MG/ML	SOLUTION / ORAL	RLD, RS	2014-03-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N205410-001	HEMANGEOL	4.28MG/ML	SOLUTION / ORAL	RLD, RS	2014-03-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N205410-001	HEMANGEOL	4.28MG/ML	SOLUTION / ORAL	RLD, RS	2014-03-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N205410-001	HEMANGEOL	4.28MG/ML	SOLUTION / ORAL	RLD, RS	2014-03-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N205410-001	HEMANGEOL	4.28MG/ML	SOLUTION / ORAL	RLD, RS	2014-03-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205410-001	HEMANGEOL	4.28MG/ML	SOLUTION / ORAL	RLD, RS	2014-03-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N205410-001	HEMANGEOL	4.28MG/ML	SOLUTION / ORAL	RLD, RS	2014-03-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N205410-001	HEMANGEOL	4.28MG/ML	SOLUTION / ORAL	RLD, RS	2014-03-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N205410-001	HEMANGEOL	4.28MG/ML	SOLUTION / ORAL	RLD, RS	2014-03-14	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N205410-001	8338489	2028-10-16	U-1496	2014-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205410-001	8987262	2028-10-16	U-1988	2017-04-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205410-001	8338489	2028-10-16	U-1496	2014-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205410-001	8987262	2028-10-16	U-1988	2017-04-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205410-001	8338489	2028-10-16	U-1496	2014-03-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205410-001	8987262	2028-10-16	U-1988	2017-04-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205410-001	8338489	2028-10-16	U-1496	2014-03-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205410-001	8987262	2028-10-16	U-1988	2017-04-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205410-001	8338489	2028-10-16	U-1496	2014-03-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205410-001	8987262	2028-10-16	U-1988	2017-04-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205410-001	8338489	2028-10-16	U-1496	2014-03-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205410-001	8987262	2028-10-16	U-1988	2017-04-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205410-001	8338489	2028-10-16	U-1496	2014-03-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205410-001	8987262	2028-10-16	U-1988	2017-04-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205410-001	8338489	2028-10-16	U-1496	2014-03-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205410-001	8987262	2028-10-16	U-1988	2017-04-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205410-001	8338489	2028-10-16	U-1496	2014-03-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205410-001	8987262	2028-10-16	U-1988	2017-04-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205410-001	8338489	2028-10-16	U-1496	2014-03-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205410-001	8987262	2028-10-16	U-1988	2017-04-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205410-001	8338489	2028-10-16	U-1496	2014-03-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205410-001	8987262	2028-10-16	U-1988	2017-04-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205410-001	8338489	2028-10-16	U-1496	2014-03-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205410-001	8987262	2028-10-16	U-1988	2017-04-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205410-001	8338489	2028-10-16	U-1496	2014-03-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205410-001	8987262	2028-10-16	U-1988	2017-04-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205410-001	8338489	2028-10-16	U-1496	2014-03-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N205410-001	8987262	2028-10-16	U-1988	2017-04-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205410-001	8338489	2028-10-16	U-1496	2014-03-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205410-001	8987262	2028-10-16	U-1988	2017-04-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205410-001	8338489	2028-10-16	U-1496	2014-03-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N205410-001	8987262	2028-10-16	U-1988	2017-04-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205410-001	8338489	2028-10-16	U-1496	2014-03-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N205410-001	8987262	2028-10-16	U-1988	2017-04-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205410-001	8338489	2028-10-16	U-1496	2014-03-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205410-001	8987262	2028-10-16	U-1988	2017-04-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N205410-001	8338489	2028-10-16	U-1496	2014-03-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N205410-001	8987262	2028-10-16	U-1988	2017-04-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205410-001	8338489	2028-10-16	U-1496	2014-03-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N205410-001	8987262	2028-10-16	U-1988	2017-04-14	`782e0a99824c…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N205410-001	ODE-62	2021-03-14	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N205410-001	ODE-62	2021-03-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205410-001	ODE-62	2021-03-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205410-001	ODE-62	2021-03-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N205410-001	ODE-62	2021-03-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205410-001	ODE-62	2021-03-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205410-001	ODE-62	2021-03-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205410-001	ODE-62	2021-03-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205410-001	ODE-62	2021-03-14	`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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HEMANGEOL	PROPRANOLOL HYDROCHLORIDE	Pierre Fabre Pharmaceuticals, Inc.	b6f9dd2a-632b-87eb-70f0-b2064d7ed48a	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205410 application number: NDA205410 ndc (product): 64370-375
HEMANGEOL	PROPRANOLOL HYDROCHLORIDE	Eton Pharmaceuticals, Inc.	4f8341ee-dac6-1ca9-e063-6394a90ac960	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205410 application number: NDA205410

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
64370-375	HEMANGEOL	propranolol hydrochloride	Pierre Fabre Pharmaceuticals, Inc.	NDA	Current
64370-375	HEMANGEOL	propranolol hydrochloride	Pierre Fabre Pharmaceuticals, Inc.	NDA	Current
64370-375	HEMANGEOL	propranolol hydrochloride	Pierre Fabre Pharmaceuticals, Inc.	NDA	Current
64370-375	HEMANGEOL	propranolol hydrochloride	Pierre Fabre Pharmaceuticals, Inc.	NDA	Current
64370-375	HEMANGEOL	propranolol hydrochloride	Pierre Fabre Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
69572	SUPPL	2021-12-15
67982	SUPPL	2021-06-30
67887	SUPPL	2021-06-24
62543	SUPPL	2020-04-10
62427	SUPPL	2020-04-03
61391	SUPPL	2019-12-23
61347	SUPPL	2019-12-19
43487	ORIG	2015-03-31
19643	ORIG	2014-03-19
10444	ORIG	2014-03-19