Application 075826

Type: ANDA
Sponsor: FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	INJECTABLE;INJECTION	1MG/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A075826-001	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP		2001-08-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A075826-001	AP

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A075826-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075826-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075826-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075826-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075826-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075826-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075826-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075826-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075826-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075826-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075826-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075826-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075826-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075826-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075826-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075826-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075826-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075826-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075826-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075826-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075826-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075826-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075826-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075826-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075826-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075826-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075826-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075826-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075826-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075826-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075826-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075826-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075826-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075826-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075826-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075826-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075826-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075826-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075826-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075826-001	AP	1	`e64feba35796…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PROPRANOLOL	PROPRANOLOL	HF Acquisition Co LLC, DBA HealthFirst	54dd0fad-64ee-788f-e063-6394a90ac88e	2026-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075826 application number: ANDA075826
Propranolol	PROPRANOLOL HYDROCHLORIDE	ProPharma Distribution	45b0aaf0-df6c-7db0-e063-6294a90a9135	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075826 application number: ANDA075826
PROPRANOLOL	PROPRANOLOL HYDROCHLORIDE	Henry Schein, Inc.	e586996d-9035-4ef4-8c8d-06e70a02577f	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075826 application number: ANDA075826
Propranolol	PROPRANOLOL HYDROCHLORIDE	Medical Purchasing Solutions, LLC	9e50d1ee-b7f3-e549-e053-2995a90a4a86	2023-05-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075826 application number: ANDA075826 ndc (product): 71872-7195
Propranolol	PROPRANOLOL HYDROCHLORIDE	Fresenius Kabi USA, LLC	f14ea537-dd5c-4c78-9037-9a85e9e610ef	2023-01-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075826 application number: ANDA075826 ndc (product): 63323-604

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
63323-604	Propranolol	PROPRANOLOL HYDROCHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-604	Propranolol	PROPRANOLOL HYDROCHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
71872-7195	Propranolol	PROPRANOLOL HYDROCHLORIDE	Medical Purchasing Solutions, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31031	ORIG	2003-04-15