Application 077760

Type: ANDA
Sponsor: HIKMA FARMACEUTICA

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	Yes

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
A077760-001	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077760-001	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A077760-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077760-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077760-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077760-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077760-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077760-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077760-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077760-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077760-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077760-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077760-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077760-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077760-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077760-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077760-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077760-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077760-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077760-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077760-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		RS	2008-01-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077760-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		RS	2008-01-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077760-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		RS	2008-01-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077760-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		RS	2008-01-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077760-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		RS	2008-01-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077760-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		RS	2008-01-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077760-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		RS	2008-01-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077760-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		RS	2008-01-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077760-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		RS	2008-01-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077760-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		RS	2008-01-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077760-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077760-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077760-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077760-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077760-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077760-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077760-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077760-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077760-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077760-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077760-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077760-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-31	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A077760-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077760-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077760-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077760-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077760-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077760-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077760-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077760-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077760-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077760-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077760-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077760-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077760-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077760-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077760-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077760-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077760-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077760-001	AP	1	`4b0b4de00fa7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077760-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077760-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077760-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077760-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077760-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077760-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077760-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077760-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077760-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077760-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077760-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077760-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077760-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A077760-001	AP	1	`a50c72e98297…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	91f2ff1d-68d8-4e83-a2db-618f0410ead7	2026-01-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077760 application number: ANDA077760 ndc (product): 0143-9872
PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	7da73cee-4e98-462d-e053-2991aa0a8bf4	2025-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077760 application number: ANDA077760 ndc (product): 51662-1338
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Medical Purchasing Solutions, LLC	693569bd-6053-5b3e-e053-2a91aa0a6e9c	2023-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077760 application number: ANDA077760 ndc (product): 71872-7096

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-9872	Propranolol Hydrochloride	Propranolol Hydrochloride	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9872	Propranolol Hydrochloride	Propranolol Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0404-9944	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	Henry Schein, Inc.	ANDA	Current
0404-9944	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	Henry Schein, Inc.	ANDA	Current
0404-9944	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	Henry Schein, Inc.	ANDA	Current
51662-1338	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1338	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1338	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1338	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
52584-872	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	General Injectables and Vaccines, Inc.	ANDA	Current
52584-872	Propranolol	Propranolol	General Injectables & Vaccines, Inc	ANDA	Current
52584-872	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	General Injectables and Vaccines, Inc.	ANDA	Current
52584-872	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	General Injectables and Vaccines, Inc.	ANDA	Current
52584-872	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	General Injectables and Vaccines, Inc.	ANDA	Current
52584-872	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	General Injectables and Vaccines, Inc.	ANDA	Current
71872-7096	Propranolol Hydrochloride	Propranolol Hydrochloride	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7096	Propranolol Hydrochloride	Propranolol Hydrochloride	Medical Purchasing Solutions, LLC	ANDA	Current