Application 074019

Type: ANDA
Sponsor: MYLAN PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PINDOLOL	PINDOLOL	TABLET;ORAL	5MG	No	No
002	PINDOLOL	PINDOLOL	TABLET;ORAL	10MG	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A074019-001	PINDOLOL	PINDOLOL	5MG	TABLET / ORAL	AB		1992-09-03
A074019-002	PINDOLOL	PINDOLOL	10MG	TABLET / ORAL	AB	RS	1992-09-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074019-001	AB
A074019-002	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 · 82 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
2026-02-19 14:30 UTC	2026-02	A074019-001	PINDOLOL	5MG	TABLET / ORAL	AB		1992-09-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074019-002	PINDOLOL	10MG	TABLET / ORAL	AB	RS	1992-09-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074019-001	PINDOLOL	5MG	TABLET / ORAL	AB		1992-09-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074019-002	PINDOLOL	10MG	TABLET / ORAL	AB	RS	1992-09-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074019-001	PINDOLOL	5MG	TABLET / ORAL	AB		1992-09-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074019-002	PINDOLOL	10MG	TABLET / ORAL	AB	RS	1992-09-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074019-001	PINDOLOL	5MG	TABLET / ORAL	AB		1992-09-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074019-002	PINDOLOL	10MG	TABLET / ORAL	AB	RS	1992-09-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074019-001	PINDOLOL	5MG	TABLET / ORAL	AB		1992-09-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074019-002	PINDOLOL	10MG	TABLET / ORAL	AB	RS	1992-09-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074019-001	PINDOLOL	5MG	TABLET / ORAL	AB		1992-09-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074019-002	PINDOLOL	10MG	TABLET / ORAL	AB	RS	1992-09-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074019-001	PINDOLOL	5MG	TABLET / ORAL	AB		1992-09-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074019-002	PINDOLOL	10MG	TABLET / ORAL	AB	RS	1992-09-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074019-001	PINDOLOL	5MG	TABLET / ORAL	AB		1992-09-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074019-002	PINDOLOL	10MG	TABLET / ORAL	AB	RS	1992-09-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074019-001	PINDOLOL	5MG	TABLET / ORAL	AB		1992-09-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074019-002	PINDOLOL	10MG	TABLET / ORAL	AB	RS	1992-09-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074019-001	PINDOLOL	5MG	TABLET / ORAL	AB		1992-09-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074019-002	PINDOLOL	10MG	TABLET / ORAL	AB	RS	1992-09-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074019-001	PINDOLOL	5MG	TABLET / ORAL	AB		1992-09-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074019-002	PINDOLOL	10MG	TABLET / ORAL	AB	RS	1992-09-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074019-001	PINDOLOL	5MG	TABLET / ORAL	AB		1992-09-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074019-002	PINDOLOL	10MG	TABLET / ORAL	AB	RS	1992-09-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074019-001	PINDOLOL	5MG	TABLET / ORAL	AB		1992-09-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074019-002	PINDOLOL	10MG	TABLET / ORAL	AB	RS	1992-09-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074019-001	PINDOLOL	5MG	TABLET / ORAL	AB		1992-09-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074019-002	PINDOLOL	10MG	TABLET / ORAL	AB	RS	1992-09-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074019-001	PINDOLOL	5MG	TABLET / ORAL	AB		1992-09-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074019-002	PINDOLOL	10MG	TABLET / ORAL	AB	RS	1992-09-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074019-001	PINDOLOL	5MG	TABLET / ORAL	AB		1992-09-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074019-002	PINDOLOL	10MG	TABLET / ORAL	AB	RS	1992-09-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074019-001	PINDOLOL	5MG	TABLET / ORAL	AB		1992-09-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074019-002	PINDOLOL	10MG	TABLET / ORAL	AB	RS	1992-09-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074019-001	PINDOLOL	5MG	TABLET / ORAL	AB		1992-09-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074019-002	PINDOLOL	10MG	TABLET / ORAL	AB	RS	1992-09-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074019-001	PINDOLOL	5MG	TABLET / ORAL	AB		1992-09-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074019-002	PINDOLOL	10MG	TABLET / ORAL	AB	RS	1992-09-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074019-001	PINDOLOL	5MG	TABLET / ORAL	AB		1992-09-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A074019-002	PINDOLOL	10MG	TABLET / ORAL	AB	RS	1992-09-03	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A074019-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074019-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074019-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074019-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074019-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074019-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074019-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074019-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074019-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074019-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074019-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074019-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074019-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074019-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074019-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074019-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074019-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074019-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074019-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074019-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074019-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074019-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074019-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074019-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074019-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074019-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074019-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074019-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074019-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074019-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074019-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074019-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074019-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074019-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074019-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074019-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074019-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074019-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074019-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A074019-002	AB	1	`782e0a99824c…`

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pindolol	PINDOLOL	PD-Rx Pharmaceuticals, Inc.	0daed7b3-6017-4611-8c3a-2f390470f8bc	2026-07-17	Warnings, Adverse reactions	Name fallback brand name: Pindolol generic name: PINDOLOL
Pindolol	PINDOLOL	PD-Rx Pharmaceuticals, Inc.	79a8d97b-9461-4914-bcbb-f6f64a39e5e7	2026-07-17	Warnings, Adverse reactions	Name fallback brand name: Pindolol generic name: PINDOLOL
Pindolol	PINDOLOL	Bryant Ranch Prepack	8498aead-0aef-4cd8-a191-05cae57a55e5	2026-05-27	Warnings, Adverse reactions	Name fallback brand name: Pindolol generic name: PINDOLOL
Pindolol	PINDOLOL	Bryant Ranch Prepack	22b95e96-ead9-4149-badb-7d33077e82ec	2026-05-27	Warnings, Adverse reactions	Name fallback brand name: Pindolol generic name: PINDOLOL
Pindolol	PINDOLOL	Sun Pharmaceutical Industries, Inc.	b331a73f-bf7b-4442-8901-36d016530279	2026-03-17	Warnings, Adverse reactions	Name fallback brand name: Pindolol generic name: PINDOLOL
Pindolol	PINDOLOL	Marlex Pharmaceuticals, Inc.	e1049edf-376e-317b-e053-2995a90a2aac	2026-02-06	Warnings, Adverse reactions	Name fallback brand name: Pindolol generic name: PINDOLOL
Pindolol	PINDOLOL	PD-Rx Pharmaceuticals, Inc.	f91e5715-e37d-45fa-97a7-4d32fbd51060	2026-01-12	Warnings, Adverse reactions	Name fallback brand name: Pindolol generic name: PINDOLOL
Pindolol	PINDOLOL	Unichem Pharmaceuticals (USA), Inc.	f529ff35-f82b-4a3a-96b4-096bfc8e81b5	2025-12-11	Warnings, Adverse reactions	Name fallback brand name: Pindolol generic name: PINDOLOL
Pindolol	PINDOLOL	Westminster Pharmaceuticals, LLC	efdb0189-37b5-45d6-b92c-1157bb9df789	2025-11-25	Warnings, Adverse reactions	Name fallback brand name: Pindolol generic name: PINDOLOL
Pindolol	PINDOLOL	ANI Pharmaceuticals, Inc.	611be921-e9b6-4800-80b2-c2d4f677cdb2	2025-09-19	Warnings, Adverse reactions	Name fallback brand name: Pindolol generic name: PINDOLOL
Pindolol	PINDOLOL	Bryant Ranch Prepack	7fb36f8f-11fe-498e-8667-daeccf8b2273	2024-11-25	Warnings, Adverse reactions	Name fallback brand name: Pindolol generic name: PINDOLOL

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-0052	Pindolol	pindolol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0052	Pindolol	pindolol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0052	Pindolol	pindolol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0127	Pindolol	pindolol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0127	Pindolol	pindolol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0127	Pindolol	pindolol	Mylan Pharmaceuticals Inc.	ANDA	Current
68151-1320	Pindolol	pindolol	Carilion Materials Management	ANDA	Current
68151-3005	Pindolol	pindolol	Carilion Materials Management	ANDA	Current