Application 071976

Type: ANDA
Sponsor: IMPAX LABS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	TABLET;ORAL	80MG	No	Yes
002	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	TABLET;ORAL	60MG	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A071976-001	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	RS	1988-04-06
A071976-002	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB		1986-05-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A071976-001	AB
A071976-002	AB

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 3 · 84 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	A071976-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	RS	1988-04-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071976-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB		1986-05-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071976-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	RS	1988-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071976-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB		1986-05-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071976-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	RS	1988-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071976-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB		1986-05-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071976-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	RS	1988-04-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071976-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB		1986-05-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071976-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	RS	1988-04-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071976-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB		1986-05-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071976-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	RS	1988-04-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071976-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB		1986-05-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071976-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	RS	1988-04-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071976-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB		1986-05-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071976-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	RS	1988-04-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071976-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB		1986-05-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071976-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	RS	1988-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071976-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB		1986-05-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071976-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	RS	1988-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071976-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB		1986-05-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071976-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	RS	1988-04-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071976-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB		1986-05-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071976-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	RS	1988-04-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071976-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB		1986-05-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071976-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	RS	1988-04-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071976-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB		1986-05-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071976-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	RS	1988-04-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071976-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB		1986-05-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071976-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	RS	1988-04-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A071976-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB		1986-05-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071976-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL			1988-04-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071976-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB		1986-05-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071976-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL			1988-04-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A071976-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB		1986-05-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071976-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL			1988-04-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A071976-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB		1986-05-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071976-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	RS	1988-04-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A071976-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB		1986-05-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071976-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL			1988-04-06	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A071976-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB		1986-05-13	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 71 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	A071976-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071976-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071976-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071976-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071976-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071976-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071976-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071976-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071976-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071976-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071976-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071976-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071976-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071976-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071976-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071976-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071976-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071976-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071976-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071976-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071976-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071976-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071976-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071976-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071976-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071976-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071976-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071976-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071976-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A071976-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071976-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071976-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071976-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071976-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A071976-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071976-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071976-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071976-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071976-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071976-002	AB	1	`8869cabd3fbd…`

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
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Amneal Pharmaceuticals NY LLC	14d0c95d-418f-40a8-bad3-e20c82424960	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071976 application number: ANDA071976 ndc (product): 69238-2080 ndc (product): 69238-2081
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Coupler LLC	3e50045f-abdf-3b78-e063-6394a90a4ba0	2025-09-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071976 application number: ANDA071976

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0115-1693	Propranolol Hydrochloride	Propranolol Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1693	Propranolol Hydrochloride	Propranolol Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
50111-471	Propranolol Hydrochloride	Propranolol Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
63629-6881	Propranolol Hydrochloride	Propranolol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
69238-2080	Propranolol Hydrochloride	Propranolol Hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-2080	Propranolol Hydrochloride	Propranolol Hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-2081	Propranolol Hydrochloride	Propranolol Hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-2081	Propranolol Hydrochloride	Propranolol Hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
71335-0405	Propranolol Hydrochloride	Propranolol Hydrochloride	Bryant Ranch Prepack	ANDA	Current