Application 212026

Type: ANDA
Sponsor: AMTA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	60MG	No	No
002	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	80MG	No	No
003	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	120MG	No	No
004	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	160MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A212026-001	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06
A212026-002	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06
A212026-003	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06
A212026-004	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A212026-001	AB
A212026-002	AB
A212026-003	AB
A212026-004	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 4 · 152 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	A212026-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212026-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212026-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212026-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212026-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212026-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212026-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212026-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212026-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212026-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212026-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212026-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212026-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212026-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212026-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212026-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212026-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212026-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212026-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212026-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212026-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212026-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212026-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212026-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212026-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212026-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212026-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212026-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212026-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212026-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212026-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212026-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212026-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212026-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212026-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212026-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212026-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212026-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212026-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212026-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 152 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	A212026-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212026-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212026-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212026-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212026-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212026-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212026-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212026-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212026-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212026-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212026-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212026-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212026-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212026-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212026-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212026-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212026-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212026-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212026-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212026-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212026-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212026-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212026-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212026-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212026-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212026-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212026-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212026-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212026-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212026-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212026-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212026-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212026-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212026-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212026-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212026-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212026-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212026-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212026-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212026-004	AB	1	`d8e5a09893c0…`

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 Hydrochloride	PROPRANOLOL HYDROCHLORIDE	REMEDYREPACK INC.	414c4b69-38a1-4220-bec8-204c9a624b85	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212026 application number: ANDA212026 ndc (product): 70518-3552
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	A-S Medication Solutions	87967c3a-4a6e-45c8-ae3d-1e1dbaa4ba10	2024-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212026 application number: ANDA212026
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	ea98fedc-c440-487e-b144-35a8a389a446	2024-09-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212026 application number: ANDA212026 ndc (product): 71335-1765
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	b9d12ace-7e30-4183-99a4-c0a5a6a55cdf	2024-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212026 application number: ANDA212026
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Lannett Company, Inc.	5229b561-287b-463c-8679-cda4c34f440b	2024-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212026 application number: ANDA212026 ndc (product): 0527-4116 ndc (product): 0527-4119 ndc (product): 0527-4118 ndc (product): 0527-4117

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0527-4116	Propranolol Hydrochloride	propranolol hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-4116	Propranolol Hydrochloride	Propranolol Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-4116	Propranolol Hydrochloride	propranolol hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-4116	Propranolol Hydrochloride	propranolol hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-4117	Propranolol Hydrochloride	propranolol hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-4117	Propranolol Hydrochloride	Propranolol Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-4117	Propranolol Hydrochloride	propranolol hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-4117	Propranolol Hydrochloride	propranolol hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-4118	Propranolol Hydrochloride	propranolol hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-4118	Propranolol Hydrochloride	Propranolol Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-4118	Propranolol Hydrochloride	propranolol hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-4118	Propranolol Hydrochloride	propranolol hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-4119	Propranolol Hydrochloride	propranolol hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-4119	Propranolol Hydrochloride	Propranolol Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-4119	Propranolol Hydrochloride	propranolol hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-4119	Propranolol Hydrochloride	propranolol hydrochloride	Lannett Company, Inc.	ANDA	Current
60760-576	Propranolol Hydrochloride	propranolol hydrochloride	ST. MARY'S MEDICAL PARK PHARMACY	ANDA	Current
70518-3465	Propranolol Hydrochloride	propranolol hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3509	Propranolol Hydrochloride	propranolol hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3552	Propranolol Hydrochloride	propranolol hydrochloride	REMEDYREPACK INC.	ANDA	Current
71335-1765	Propranolol Hydrochloride	propranolol hydrochloride	Bryant Ranch Prepack	ANDA	Current