Application 213136

Type: ANDA
Sponsor: UNICHEM LABS LTD

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
A213136-001	ATENOLOL	ATENOLOL	25MG	TABLET / ORAL	AB	2019-11-21
A213136-002	ATENOLOL	ATENOLOL	50MG	TABLET / ORAL	AB	2019-11-21
A213136-003	ATENOLOL	ATENOLOL	100MG	TABLET / ORAL	AB	2019-11-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213136-001	AB
A213136-002	AB
A213136-003	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 3 · 114 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	A213136-001	ATENOLOL	25MG	TABLET / ORAL	AB	2019-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213136-002	ATENOLOL	50MG	TABLET / ORAL	AB	2019-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213136-003	ATENOLOL	100MG	TABLET / ORAL	AB	2019-11-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213136-001	ATENOLOL	25MG	TABLET / ORAL	AB	2019-11-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213136-002	ATENOLOL	50MG	TABLET / ORAL	AB	2019-11-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213136-003	ATENOLOL	100MG	TABLET / ORAL	AB	2019-11-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213136-001	ATENOLOL	25MG	TABLET / ORAL	AB	2019-11-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213136-002	ATENOLOL	50MG	TABLET / ORAL	AB	2019-11-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213136-003	ATENOLOL	100MG	TABLET / ORAL	AB	2019-11-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213136-001	ATENOLOL	25MG	TABLET / ORAL	AB	2019-11-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213136-002	ATENOLOL	50MG	TABLET / ORAL	AB	2019-11-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213136-003	ATENOLOL	100MG	TABLET / ORAL	AB	2019-11-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213136-001	ATENOLOL	25MG	TABLET / ORAL	AB	2019-11-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213136-002	ATENOLOL	50MG	TABLET / ORAL	AB	2019-11-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213136-003	ATENOLOL	100MG	TABLET / ORAL	AB	2019-11-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213136-001	ATENOLOL	25MG	TABLET / ORAL	AB	2019-11-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213136-002	ATENOLOL	50MG	TABLET / ORAL	AB	2019-11-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213136-003	ATENOLOL	100MG	TABLET / ORAL	AB	2019-11-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213136-001	ATENOLOL	25MG	TABLET / ORAL	AB	2019-11-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213136-002	ATENOLOL	50MG	TABLET / ORAL	AB	2019-11-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213136-003	ATENOLOL	100MG	TABLET / ORAL	AB	2019-11-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213136-001	ATENOLOL	25MG	TABLET / ORAL	AB	2019-11-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213136-002	ATENOLOL	50MG	TABLET / ORAL	AB	2019-11-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213136-003	ATENOLOL	100MG	TABLET / ORAL	AB	2019-11-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213136-001	ATENOLOL	25MG	TABLET / ORAL	AB	2019-11-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213136-002	ATENOLOL	50MG	TABLET / ORAL	AB	2019-11-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213136-003	ATENOLOL	100MG	TABLET / ORAL	AB	2019-11-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213136-001	ATENOLOL	25MG	TABLET / ORAL	AB	2019-11-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213136-002	ATENOLOL	50MG	TABLET / ORAL	AB	2019-11-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213136-003	ATENOLOL	100MG	TABLET / ORAL	AB	2019-11-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213136-001	ATENOLOL	25MG	TABLET / ORAL	AB	2019-11-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213136-002	ATENOLOL	50MG	TABLET / ORAL	AB	2019-11-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213136-003	ATENOLOL	100MG	TABLET / ORAL	AB	2019-11-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213136-001	ATENOLOL	25MG	TABLET / ORAL	AB	2019-11-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213136-002	ATENOLOL	50MG	TABLET / ORAL	AB	2019-11-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213136-003	ATENOLOL	100MG	TABLET / ORAL	AB	2019-11-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213136-001	ATENOLOL	25MG	TABLET / ORAL	AB	2019-11-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213136-002	ATENOLOL	50MG	TABLET / ORAL	AB	2019-11-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213136-003	ATENOLOL	100MG	TABLET / ORAL	AB	2019-11-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213136-001	ATENOLOL	25MG	TABLET / ORAL	AB	2019-11-21	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 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	A213136-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213136-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213136-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213136-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213136-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213136-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213136-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213136-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213136-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213136-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213136-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213136-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213136-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213136-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213136-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213136-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213136-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213136-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213136-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213136-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213136-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213136-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213136-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213136-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213136-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213136-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213136-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213136-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213136-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213136-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213136-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213136-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213136-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213136-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213136-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213136-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213136-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213136-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213136-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213136-001	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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atenolol	ATENOLOL	ASCLEMED USA INC.	2ee7b7da-303d-4a57-a1eb-25e8923660c0	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213136 application number: ANDA213136
Atenolol	ATENOLOL	Preferred Pharmaceuticals Inc.	0ad0c7dd-e4e5-4968-9372-7a9bb30073ec	2026-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213136 application number: ANDA213136
Atenolol	ATENOLOL	Preferred Pharmaceuticals Inc.	5ad1426a-5a74-427b-812d-c7b144c84474	2026-03-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213136 application number: ANDA213136
Atenolol	ATENOLOL	A-S Medication Solutions	d7a93c64-0c52-4d72-a9be-37c7ca355cdf	2026-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213136 application number: ANDA213136 ndc (product): 50090-6311
Atenolol	ATENOLOL	Bryant Ranch Prepack	290f4de3-8815-466c-81dc-8bc632375896	2025-10-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213136 application number: ANDA213136
Atenolol	ATENOLOL	REMEDYREPACK INC.	897e18f6-3b57-4ef0-85ff-9dfa23521eb9	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213136 application number: ANDA213136
Atenolol	ATENOLOL	A-S Medication Solutions	3d35592c-91ac-44f6-b077-5963e952f0dd	2025-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213136 application number: ANDA213136
Atenolol	ATENOLOL	A-S Medication Solutions	f419c72e-f1f9-4b5a-94ff-a525367cdce4	2025-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213136 application number: ANDA213136 ndc (product): 50090-6241
Atenolol	ATENOLOL	A-S Medication Solutions	d3e72119-e3c3-41ba-8787-acc86b44d6c4	2025-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213136 application number: ANDA213136 ndc (product): 50090-5363
Atenolol	ATENOLOL	A-S Medication Solutions	a3c8d507-e040-409e-9f97-742925cc66a1	2025-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213136 application number: ANDA213136
Atenolol 29300-411	ATENOLOL	NuCare Pharmaceuticals,Inc.	239b1cce-3b1a-f049-e063-6394a90a0e0a	2024-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213136 application number: ANDA213136
Atenolol	ATENOLOL	Quality Care Products, LLC	4fc4a969-286f-4fd2-b16a-f0291fd1c5c0	2024-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213136 application number: ANDA213136
Atenolol	ATENOLOL	Bryant Ranch Prepack	bd0f7f1c-dd20-4de6-a012-f581a216f23f	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213136 application number: ANDA213136 ndc (product): 71335-9611
Atenolol	ATENOLOL	Unichem Pharmaceuticals (USA), Inc.	35d99c43-7305-4a4a-886e-a9bf3ee88fa8	2024-01-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213136 application number: ANDA213136 ndc (product): 29300-410 ndc (product): 29300-411 ndc (product): 29300-412

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
29300-410	Atenolol	Atenolol	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-410	Atenolol	Atenolol	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-410	Atenolol	Atenolol	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-410	Atenolol	Atenolol	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-411	Atenolol	Atenolol	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-411	Atenolol	Atenolol	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-411	Atenolol	Atenolol	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-411	Atenolol	Atenolol	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-412	Atenolol	Atenolol	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-412	Atenolol	Atenolol	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-412	Atenolol	Atenolol	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-412	Atenolol	Atenolol	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
50090-5363	Atenolol	Atenolol	A-S Medication Solutions	ANDA	Current
50090-5363	Atenolol	Atenolol	A-S Medication Solutions	ANDA	Current
50090-5363	Atenolol	Atenolol	A-S Medication Solutions	ANDA	Current
50090-6241	Atenolol	Atenolol	A-S Medication Solutions	ANDA	Current
50090-6311	Atenolol	Atenolol	A-S Medication Solutions	ANDA	Current
71335-9611	Atenolol	Atenolol	Bryant Ranch Prepack	ANDA	Current