Application 078512

Type: ANDA
Sponsor: AUROBINDO PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ATENOLOL	ATENOLOL	TABLET;ORAL	25MG	No	No
002	ATENOLOL	ATENOLOL	TABLET;ORAL	50MG	No	No
003	ATENOLOL	ATENOLOL	TABLET;ORAL	100MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A078512-001	ATENOLOL	ATENOLOL	25MG	TABLET / ORAL	AB	2007-10-31
A078512-002	ATENOLOL	ATENOLOL	50MG	TABLET / ORAL	AB	2007-10-31
A078512-003	ATENOLOL	ATENOLOL	100MG	TABLET / ORAL	AB	2007-10-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A078512-001	AB
A078512-002	AB
A078512-003	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 · 123 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
2026-02-19 14:30 UTC	2026-02	A078512-001	ATENOLOL	25MG	TABLET / ORAL	AB	2007-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078512-002	ATENOLOL	50MG	TABLET / ORAL	AB	2007-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078512-003	ATENOLOL	100MG	TABLET / ORAL	AB	2007-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078512-001	ATENOLOL	25MG	TABLET / ORAL	AB	2007-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078512-002	ATENOLOL	50MG	TABLET / ORAL	AB	2007-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078512-003	ATENOLOL	100MG	TABLET / ORAL	AB	2007-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078512-001	ATENOLOL	25MG	TABLET / ORAL	AB	2007-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078512-002	ATENOLOL	50MG	TABLET / ORAL	AB	2007-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078512-003	ATENOLOL	100MG	TABLET / ORAL	AB	2007-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078512-001	ATENOLOL	25MG	TABLET / ORAL	AB	2007-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078512-002	ATENOLOL	50MG	TABLET / ORAL	AB	2007-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078512-003	ATENOLOL	100MG	TABLET / ORAL	AB	2007-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078512-001	ATENOLOL	25MG	TABLET / ORAL	AB	2007-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078512-002	ATENOLOL	50MG	TABLET / ORAL	AB	2007-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078512-003	ATENOLOL	100MG	TABLET / ORAL	AB	2007-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078512-001	ATENOLOL	25MG	TABLET / ORAL	AB	2007-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078512-002	ATENOLOL	50MG	TABLET / ORAL	AB	2007-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078512-003	ATENOLOL	100MG	TABLET / ORAL	AB	2007-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078512-001	ATENOLOL	25MG	TABLET / ORAL	AB	2007-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078512-002	ATENOLOL	50MG	TABLET / ORAL	AB	2007-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078512-003	ATENOLOL	100MG	TABLET / ORAL	AB	2007-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078512-001	ATENOLOL	25MG	TABLET / ORAL	AB	2007-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078512-002	ATENOLOL	50MG	TABLET / ORAL	AB	2007-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078512-003	ATENOLOL	100MG	TABLET / ORAL	AB	2007-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078512-001	ATENOLOL	25MG	TABLET / ORAL	AB	2007-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078512-002	ATENOLOL	50MG	TABLET / ORAL	AB	2007-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078512-003	ATENOLOL	100MG	TABLET / ORAL	AB	2007-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078512-001	ATENOLOL	25MG	TABLET / ORAL	AB	2007-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078512-002	ATENOLOL	50MG	TABLET / ORAL	AB	2007-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078512-003	ATENOLOL	100MG	TABLET / ORAL	AB	2007-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078512-001	ATENOLOL	25MG	TABLET / ORAL	AB	2007-10-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078512-002	ATENOLOL	50MG	TABLET / ORAL	AB	2007-10-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078512-003	ATENOLOL	100MG	TABLET / ORAL	AB	2007-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078512-001	ATENOLOL	25MG	TABLET / ORAL	AB	2007-10-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078512-002	ATENOLOL	50MG	TABLET / ORAL	AB	2007-10-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078512-003	ATENOLOL	100MG	TABLET / ORAL	AB	2007-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078512-001	ATENOLOL	25MG	TABLET / ORAL	AB	2007-10-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078512-002	ATENOLOL	50MG	TABLET / ORAL	AB	2007-10-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078512-003	ATENOLOL	100MG	TABLET / ORAL	AB	2007-10-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078512-001	ATENOLOL	25MG	TABLET / ORAL	AB	2007-10-31	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A078512-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078512-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078512-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078512-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078512-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078512-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078512-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078512-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078512-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078512-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078512-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078512-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078512-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078512-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078512-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078512-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078512-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078512-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078512-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078512-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078512-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078512-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078512-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078512-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078512-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078512-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078512-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078512-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078512-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078512-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078512-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078512-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078512-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078512-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078512-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078512-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078512-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078512-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078512-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078512-001	AB	1	`8072bd15b7f6…`

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 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atenolol	ATENOLOL	Coupler LLC	5126a70e-632d-e626-e063-6394a90ab791	2026-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078512 application number: ANDA078512
Atenolol	ATENOLOL	Coupler LLC	50760735-9305-0bbf-e063-6294a90a5b4c	2026-04-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078512 application number: ANDA078512
Atenolol	ATENOLOL	Coupler LLC	50762eee-e139-4d7f-e063-6294a90a777c	2026-04-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078512 application number: ANDA078512
Atenolol	ATENOLOL	REMEDYREPACK INC.	f5c86a73-70b6-46b2-ad9a-272c8d4673e9	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078512 application number: ANDA078512 ndc (product): 70518-3531
Atenolol	ATENOLOL	REMEDYREPACK INC.	4ca8dd77-cdac-41fe-a742-b1b32551203b	2026-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078512 application number: ANDA078512 ndc (product): 70518-3036
Atenolol	ATENOLOL	Northwind Health Company, LLC	f31b11ed-2ff6-5cfc-e053-2a95a90af2ca	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078512 application number: ANDA078512
Atenolol	ATENOLOL	Northwind Health Company, LLC	f76d03b8-f8d6-59b8-e053-6394a90a3a3f	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078512 application number: ANDA078512
Atenolol	ATENOLOL	Northwind Health Company, LLC	f2b335b4-93d2-0459-e053-2a95a90a1a5b	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078512 application number: ANDA078512
Atenolol	ATENOLOL	QPharma Inc	f682a775-2255-05e2-e053-2a95a90ac3f3	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078512 application number: ANDA078512
Atenolol	ATENOLOL	NuCare Pharmaceuticals,Inc.	331128cc-f56e-4329-e063-6394a90a5ead	2025-11-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078512 application number: ANDA078512
Atenolol	ATENOLOL	NuCare Pharmaceuticals,Inc.	410c48ae-582a-2ab2-e063-6294a90af27c	2025-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078512 application number: ANDA078512
Atenolol	ATENOLOL	REMEDYREPACK INC.	cdca0ef8-2ac3-4430-a662-f88522f68d8e	2025-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078512 application number: ANDA078512
Atenolol	ATENOLOL	Preferred Pharmaceuticals Inc.	0f744371-94fa-419d-bfed-b22301dde8b8	2025-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078512 application number: ANDA078512
Atenolol	ATENOLOL	Major Pharmaceuticals	4555261d-a997-4aa5-aba8-81aac7033787	2025-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078512 application number: ANDA078512 ndc (product): 0904-7187
Atenolol	ATENOLOL	Bryant Ranch Prepack	09b21985-1818-449d-9b29-98f733cf7b9f	2024-11-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078512 application number: ANDA078512
Atenolol	ATENOLOL	Preferred Pharmaceuticals Inc.	2ae158bb-aa03-4b44-916b-1fcfc84b4fd0	2024-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078512 application number: ANDA078512 ndc (product): 68788-7876
Atenolol	ATENOLOL	Aurobindo Pharma Limited	1b8a4689-3916-4f4b-b54a-bbb4e322d79b	2024-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078512 application number: ANDA078512 ndc (product): 65862-170 ndc (product): 65862-169 ndc (product): 65862-168
Atenolol	ATENOLOL	A-S Medication Solutions	a0e3b2a5-5ea1-4549-8144-bd059f7966f0	2023-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078512 application number: ANDA078512 ndc (product): 50090-5738
Atenolol	ATENOLOL	A-S Medication Solutions	98471493-56ee-47a4-9120-0975c265361e	2023-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078512 application number: ANDA078512 ndc (product): 50090-5741

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 36 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-7187	Atenolol	Atenolol	Major Pharmaceuticals	ANDA	Current
13107-168	Atenolol	Atenolol	Aurolife Pharma LLC	ANDA	Current
13107-169	Atenolol	Atenolol	Aurolife Pharma LLC	ANDA	Current
13107-170	Atenolol	Atenolol	Aurolife Pharma LLC	ANDA	Current
50090-5738	Atenolol	Atenolol	A-S Medication Solutions	ANDA	Current
50090-5741	Atenolol	Atenolol	A-S Medication Solutions	ANDA	Current
51138-096	Atenolol	Atenolol	Med-Health Pharma, LLC	ANDA	Current
51138-097	Atenolol	Atenolol	Med-Health Pharma, LLC	ANDA	Current
51138-098	Atenolol	Atenolol	Med-Health Pharma, LLC	ANDA	Current
53808-0658	Atenolol	Atenolol	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0660	Atenolol	Atenolol	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0900	Atenolol	Atenolol	State of Florida DOH Central Pharmacy	ANDA	Current
65862-168	Atenolol	Atenolol	Aurobindo Pharma Limited	ANDA	Current
65862-168	Atenolol	Atenolol	Aurobindo Pharma Limited	ANDA	Current
65862-168	Atenolol	Atenolol	Aurobindo Pharma Limited	ANDA	Current
65862-168	Atenolol	Atenolol	Aurobindo Pharma Limited	ANDA	Current
65862-168	Atenolol	Atenolol	Aurobindo Pharma Limited	ANDA	Current
65862-169	Atenolol	Atenolol	Aurobindo Pharma Limited	ANDA	Current
65862-169	Atenolol	Atenolol	Aurobindo Pharma Limited	ANDA	Current
65862-169	Atenolol	Atenolol	Aurobindo Pharma Limited	ANDA	Current
65862-169	Atenolol	Atenolol	Aurobindo Pharma Limited	ANDA	Current
65862-169	Atenolol	Atenolol	Aurobindo Pharma Limited	ANDA	Current
65862-170	Atenolol	Atenolol	Aurobindo Pharma Limited	ANDA	Current
65862-170	Atenolol	Atenolol	Aurobindo Pharma Limited	ANDA	Current
65862-170	Atenolol	Atenolol	Aurobindo Pharma Limited	ANDA	Current
65862-170	Atenolol	Atenolol	Aurobindo Pharma Limited	ANDA	Current
65862-170	Atenolol	Atenolol	Aurobindo Pharma Limited	ANDA	Current
68788-7876	Atenolol	Atenolol	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7876	Atenolol	Atenolol	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7876	Atenolol	Atenolol	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-3036	Atenolol	Atenolol	REMEDYREPACK INC.	ANDA	Current
70518-3036	Atenolol	Atenolol	REMEDYREPACK INC.	ANDA	Current
70518-3036	Atenolol	Atenolol	REMEDYREPACK INC.	ANDA	Current
70518-3036	Atenolol	Atenolol	REMEDYREPACK INC.	ANDA	Current
70518-3531	Atenolol	Atenolol	REMEDYREPACK INC.	ANDA	Current
70518-3531	Atenolol	Atenolol	REMEDYREPACK INC.	ANDA	Current