Application 075792

Type: ANDA
Sponsor: ATHENEX INC

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
A075792-001	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION			2000-08-29

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	A075792-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		2000-08-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075792-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		2000-08-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075792-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		2000-08-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075792-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		2000-08-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075792-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		2000-08-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075792-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		2000-08-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075792-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		2000-08-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075792-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		2000-08-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075792-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		2000-08-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075792-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		2000-08-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075792-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		2000-08-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075792-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		2000-08-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075792-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		2000-08-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075792-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		2000-08-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075792-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		2000-08-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075792-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		2000-08-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075792-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		2000-08-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075792-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		2000-08-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075792-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2000-08-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075792-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2000-08-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075792-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2000-08-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075792-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2000-08-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075792-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2000-08-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075792-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2000-08-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075792-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2000-08-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075792-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2000-08-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075792-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2000-08-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075792-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2000-08-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075792-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		2000-08-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075792-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		2000-08-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075792-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		2000-08-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075792-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		2000-08-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075792-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		2000-08-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075792-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		2000-08-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075792-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		2000-08-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075792-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		2000-08-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075792-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		2000-08-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075792-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		2000-08-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075792-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		2000-08-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075792-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		2000-08-29	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A075792-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075792-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075792-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075792-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075792-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075792-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075792-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075792-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075792-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075792-001	AP	1	`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 7 · 139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	52da1afc-7f1c-4893-ab84-8479dd939951	2026-08-24	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	86c48c5a-0a59-43a7-b3b5-41ab5da72ce1	2026-08-24	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	582fe781-0759-4622-8fa6-b7d90e94e696	2026-08-24	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	1791ef4d-b609-41c8-b4ef-15bff752ddd7	2026-08-24	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	d9759182-e681-4c7e-af36-9f7b2184df3c	2026-08-24	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	REMEDYREPACK INC.	a3bd3ef9-539d-450e-900b-95be0e46095b	2026-08-10	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	PAI Holdings, LLC dba PAI Pharma	fa5b6189-3419-4134-8bfe-c0d0c77df828	2026-08-10	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	REMEDYREPACK INC.	e3f615e0-07da-491c-9620-7083f4f4318a	2026-08-07	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	REMEDYREPACK INC.	1cd914b6-b250-4b11-8404-41db3589361e	2026-08-05	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	REMEDYREPACK INC.	07c3fcab-33fe-4a6a-ba67-2d042190c146	2026-08-04	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	49d09308-74b0-4f9a-9c03-37234b5ee3a3	2026-07-29	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Cardinal Health 107, LLC	1df7f35e-b1d8-4aca-875e-d197cb61239e	2026-07-29	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	A-S Medication Solutions	1bb6d65a-8264-4fa4-92d4-c4a756ec49ea	2026-07-29	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	American Health Packaging	c751ee54-27b4-4ed7-829a-ced735c41312	2026-07-20	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	95a2eacd-b6b7-4e92-ae14-52fbee6c6543	2026-07-20	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Cardinal Health 107, LLC	63abab85-ec88-4fcf-a8e7-0850e5f797ee	2026-07-20	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	REMEDYREPACK INC.	554c7446-8407-460e-b157-f860c5afbf12	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Major Pharmaceuticals	e7218c9b-b9b8-4cf0-a2c7-c759ad3a65ba	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	ATLANTIC BIOLOGICALS CORP.	b609cc7c-1f6a-452b-8ada-c4d2989b83dc	2026-07-10	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
propranolol hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	4803b5bf-8ca4-4a8b-bd24-1f3ff7d93d7e	2026-07-08	Warnings, Adverse reactions	Name fallback brand name: propranolol hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31019	ORIG	2000-08-29