Application 076958

Type: ANDA
Sponsor: TEVA

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	Approval date
A076958-001	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-04-06
A076958-002	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-04-06
A076958-003	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-04-06

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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076958-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-04-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076958-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-04-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076958-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-04-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076958-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-04-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076958-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-04-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076958-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-04-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076958-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076958-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076958-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-04-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076958-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076958-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076958-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-04-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076958-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-04-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076958-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-04-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076958-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-04-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076958-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-04-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076958-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-04-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076958-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-04-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076958-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-04-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076958-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-04-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076958-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-04-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076958-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-04-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076958-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-04-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076958-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-04-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076958-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-04-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076958-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-04-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076958-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-04-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076958-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076958-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076958-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-04-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076958-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076958-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076958-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-04-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076958-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-04-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076958-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-04-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076958-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-04-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076958-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-04-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076958-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-04-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076958-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-04-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076958-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-04-06	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-07-19 19:46 UTC	2019-07	A076958-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076958-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076958-003	AB	1	`ea99ee380514…`

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 7 of 7 · 137 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	XLCare Pharmaceuticals, Inc.	20421665-0401-4f6e-9e1d-232c654efb0f	2023-01-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LOSARTAN POTASSIUM generic name: LOSARTAN POTASSIUM
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	Aphena Pharma Solutions - Tennessee, LLC	8015c22c-d944-4a49-8721-70d0c1b98526	2022-10-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LOSARTAN POTASSIUM generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	Proficient Rx LP	5b1f6677-9473-467f-9fb6-efadbd8828e8	2022-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	Proficient Rx LP	c0319153-3e35-4a84-aa63-935b1e0047d8	2022-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	Proficient Rx LP	1b3c03e8-da8e-4c25-a493-118e760a003b	2022-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	Proficient Rx LP	aeb4ce44-ab34-4f0e-a674-de42d404d104	2022-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
LOSARTAN POTASSIUM 25 mg	LOSARTAN POTASSIUM	Proficient Rx LP	e8075254-cdfd-44f3-a9c2-1ed913f846ea	2022-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOSARTAN POTASSIUM
LOSARTAN POTASSIUM 50 mg	LOSARTAN POTASSIUM	Proficient Rx LP	f260f7c5-a55b-4294-ae02-2586929e24c9	2021-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	Proficient Rx LP	435c5544-491b-476a-b950-712b2c18e334	2020-12-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	Aphena Pharma Solutions - Tennessee, LLC	2f738295-53d6-4d4f-8864-9faf893dbdf2	2020-10-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LOSARTAN POTASSIUM generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	Aphena Pharma Solutions - Tennessee, LLC	be2432ba-2118-418a-addf-56db9b6c39d2	2020-10-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losortan Potassium	LOSARTAN POTASSIUM	Proficient Rx LP	364fe10e-11ca-4ee6-9f67-c85dec09aca5	2019-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	Proficient Rx LP	44050993-c20e-45d4-baeb-f77d91296168	2019-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	Aphena Pharma Solutions - Tennessee, LLC	35e3472a-457f-4f95-a78d-dbff2595171d	2019-01-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	Aphena Pharma Solutions - Tennessee, LLC	1f55aaa2-5848-47e0-bba0-6a70b2fa05dd	2018-12-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	Aphena Pharma Solutions - Tennessee, LLC	3bcbcb6c-ee8d-44b1-9c78-92712291e891	2018-10-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	Aphena Pharma Solutions - Tennessee, LLC	8081b9f8-0b52-46dd-93f2-6bc608b75339	2018-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 45 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-7364	Losartan Potassium	Losartan Potassium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7365	Losartan Potassium	Losartan Potassium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7366	Losartan Potassium	Losartan Potassium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0179-0200	Losartan Potassium	Losartan Potassium	KAISER FOUNDATION HOSPITALS	ANDA	Current
0179-0202	Losartan Potassium	Losartan Potassium	KAISER FOUNDATION HOSPITALS	ANDA	Current
0179-0203	Losartan Potassium	Losartan Potassium	KAISER FOUNDATION HOSPITALS	ANDA	Current
0615-7604	Losartan Potassium	Losartan Potassium	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7605	Losartan Potassium	Losartan Potassium	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7606	Losartan Potassium	Losartan Potassium	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
42708-035	Losartan Potassium	Losartan Potassium	QPharma Inc	ANDA	Current
42708-035	Losartan Potassium	Losartan Potassium	QPharma Inc	ANDA	Current
43063-766	Losartan Potassium	Losartan Potassium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
53002-1624	Losartan Potassium	Losartan Potassium	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-1624	Losartan Potassium	Losartan Potassium	RPK Pharmaceuticals, Inc.	ANDA	Current
60429-863	Losartan Potassium	Losartan Potassium	Golden State Medical Supply, Inc.	ANDA	Current
60429-863	Losartan Potassium	Losartan Potassium	Golden State Medical Supply, Inc.	ANDA	Current
60429-863	Losartan Potassium	Losartan Potassium	Golden State Medical Supply, Inc.	ANDA	Current
60429-864	Losartan Potassium	Losartan Potassium	Golden State Medical Supply, Inc.	ANDA	Current
60429-864	Losartan Potassium	Losartan Potassium	Golden State Medical Supply, Inc.	ANDA	Current
60429-865	Losartan Potassium	Losartan Potassium	Golden State Medical Supply, Inc.	ANDA	Current
60429-865	Losartan Potassium	Losartan Potassium	Golden State Medical Supply, Inc.	ANDA	Current
63187-589	Losartan Potassium	Losartan Potassium	Proficient Rx LP	ANDA	Current
63187-935	Losartan Potassium	Losartan Potassium	Proficient Rx LP	ANDA	Current
63187-935	Losartan Potassium	Losartan Potassium	Proficient Rx LP	ANDA	Current
63629-6381	Losartan Potassium	Losartan Potassium	Bryant Ranch Prepack	ANDA	Current
66116-452	Losartan Potassium	Losartan Potassium	MedVantx, Inc.	ANDA	Current
66336-665	Losartan Potassium	Losartan Potassium	Dispensing Solutions, Inc.	ANDA	Current
66336-666	Losartan Potassium	Losartan Potassium	Dispensing Solutions, Inc.	ANDA	Current
68071-1989	Losartan Potassium	Losartan Potassium	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-3003	Losartan Potassium	Losartan Potassium	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-3139	Losartan Potassium	Losartan Potassium	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-4000	Losartan Potassium	Losartan Potassium	NuCare Pharmaceuticals, Inc.	ANDA	Current
68151-0183	Losartan Potassium	Losartan Potassium	Carilion Materials Management	ANDA	Current
68645-407	Losartan Potassium	Losartan Potassium	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-409	Losartan Potassium	Losartan Potassium	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-411	Losartan Potassium	Losartan Potassium	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68788-7365	Losartan Potassium	Losartan Potassium	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-0083	Losartan Potassium	Losartan Potassium	REMEDYREPACK INC.	ANDA	Current
70518-0626	Losartan Potassium	Losartan Potassium	REMEDYREPACK INC.	ANDA	Current
70518-0626	Losartan Potassium	Losartan Potassium	REMEDYREPACK INC.	ANDA	Current
70518-0760	Losartan Potassium	Losartan Potassium	REMEDYREPACK INC.	ANDA	Current
70518-0760	Losartan Potassium	Losartan Potassium	REMEDYREPACK INC.	ANDA	Current
71610-009	Losartan Potassium	Losartan Potassium	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-009	Losartan Potassium	Losartan Potassium	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-065	Losartan Potassium	Losartan Potassium	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31178	ORIG	2010-04-16