Application 075636

Type: ANDA
Sponsor: SANDOZ

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LOVASTATIN	LOVASTATIN	TABLET;ORAL	10MG	No	No
002	LOVASTATIN	LOVASTATIN	TABLET;ORAL	20MG	No	No
003	LOVASTATIN	LOVASTATIN	TABLET;ORAL	40MG	No	No

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

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
A075636-001	LOVASTATIN	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17
A075636-002	LOVASTATIN	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17
A075636-003	LOVASTATIN	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075636-001	AB
A075636-002	AB
A075636-003	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 · 126 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	A075636-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075636-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075636-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075636-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075636-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075636-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075636-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075636-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075636-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075636-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075636-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075636-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075636-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075636-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075636-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075636-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075636-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075636-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075636-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075636-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075636-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075636-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075636-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075636-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075636-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075636-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075636-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075636-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075636-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075636-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075636-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075636-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075636-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075636-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075636-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075636-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075636-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075636-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075636-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075636-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A075636-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075636-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075636-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075636-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075636-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075636-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075636-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075636-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075636-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075636-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075636-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075636-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075636-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075636-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075636-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075636-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075636-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075636-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075636-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075636-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075636-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075636-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075636-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075636-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075636-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075636-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075636-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075636-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075636-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075636-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075636-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075636-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075636-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075636-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075636-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075636-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075636-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075636-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075636-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075636-001	AB	1	`1e350fbaab3a…`

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 3 · 56 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lovastatin	LOVASTATIN	REMEDYREPACK INC.	9438d8a0-ca5b-4676-aab9-d0241ccff6c9	2026-07-23	Warnings, Adverse reactions	Name fallback brand name: Lovastatin generic name: LOVASTATIN
Lovastatin	LOVASTATIN	PD-Rx Pharmaceuticals, Inc.	e75b5808-ec66-4da7-90bc-e53611aa1b34	2026-06-12	Warnings, Adverse reactions	Name fallback brand name: Lovastatin generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Preferred Pharmaceuticals Inc.	56680dfa-abe6-4587-b222-364315fd78f4	2026-06-03	Warnings, Adverse reactions	Name fallback brand name: Lovastatin generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Preferred Pharmaceuticals, Inc.	397949f9-ce60-424f-9902-90e65a34f4de	2026-06-03	Warnings, Adverse reactions	Name fallback brand name: Lovastatin generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Preferred Pharmaceuticals, Inc.	22c9f2d8-7bcd-4415-bbc8-505720033966	2026-06-03	Warnings, Adverse reactions	Name fallback brand name: Lovastatin generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Preferred Pharmaceuticals, Inc.	ea4df37b-21e9-4dc3-83af-1be1b50bfdc9	2026-06-03	Warnings, Adverse reactions	Name fallback brand name: Lovastatin generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Bryant Ranch Prepack	030c0f79-6bb5-4876-bf8e-b7a25b25dd38	2026-05-29	Warnings, Adverse reactions	Name fallback brand name: Lovastatin generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Bryant Ranch Prepack	f5f265a6-2aa5-4205-9159-40133ae93ac0	2026-05-28	Warnings, Adverse reactions	Name fallback brand name: Lovastatin generic name: LOVASTATIN
Lovastatin	LOVASTATIN	BluePoint Laboratories	7b86160d-74a9-4774-b5b3-5641e686991f	2026-05-27	Warnings, Adverse reactions	Name fallback brand name: Lovastatin generic name: LOVASTATIN
Lovastatin	LOVASTATIN	REMEDYREPACK INC.	ff040b3c-6790-40d7-bd64-a4073b4a2045	2026-05-21	Warnings, Adverse reactions	Name fallback brand name: Lovastatin generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Lupin Pharmaceuticals, Inc.	df7ddf4f-d569-431e-81f1-9129d7043150	2026-05-06	Warnings, Adverse reactions	Name fallback brand name: Lovastatin generic name: LOVASTATIN
Lovastatin	LOVASTATIN	REMEDYREPACK INC.	a902a95f-072a-4487-99a9-109a93f8b23c	2026-04-03	Warnings, Adverse reactions	Name fallback brand name: Lovastatin generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Legacy Pharmaceutical Packaging, LLC	a4f02fa1-3281-46fa-bd52-323e2644b6f8	2026-03-11	Warnings, Adverse reactions	Name fallback brand name: Lovastatin generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Bryant Ranch Prepack	7fd9d5c7-8025-4049-8b5b-ae3d22db507f	2026-03-09	Warnings, Adverse reactions	Name fallback brand name: Lovastatin generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Northwind Health Company, LLC	f308fe1c-23a9-6409-e053-2995a90abfd9	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Lovastatin generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Northwind Health Company, LLC	ca59cbd4-a4c1-aebe-e053-2a95a90ae968	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Lovastatin generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Northwind Health Company, LLC	db47ddae-c574-427f-e053-2a95a90aae48	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Lovastatin generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Northwind Health Company, LLC	f99e0b4c-e757-4ccd-e053-6294a90ab722	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Lovastatin generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Golden State Medical Supply, Inc.	91332c54-1a27-4e6b-e053-2a95a90a42cd	2025-12-15	Warnings, Adverse reactions	Name fallback brand name: Lovastatin generic name: LOVASTATIN
Lovastatin	LOVASTATIN	A-S Medication Solutions	06b8c398-ce2e-42c1-b1a8-73cc59a080db	2025-10-15	Warnings, Adverse reactions	Name fallback brand name: Lovastatin generic name: LOVASTATIN

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0185-0070	Lovastatin	Lovastatin	Eon Labs, Inc.	ANDA	Current
0185-0070	Lovastatin	Lovastatin	Eon Labs, Inc.	ANDA	Current
0185-0072	Lovastatin	Lovastatin	Eon Labs, Inc.	ANDA	Current
0185-0072	Lovastatin	Lovastatin	Eon Labs, Inc.	ANDA	Current
0185-0074	Lovastatin	Lovastatin	Eon Labs, Inc.	ANDA	Current
0185-0074	Lovastatin	Lovastatin	Eon Labs, Inc.	ANDA	Current
50090-2278	Lovastatin	Lovastatin	A-S Medication Solutions	ANDA	Current
61919-676	LOVASTATIN	LOVASTATIN	DIRECT RX	ANDA	Current
61919-676	LOVASTATIN	LOVASTATIN	DIRECT RX	ANDA	Current
66267-555	Lovastatin	Lovastatin	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-555	Lovastatin	Lovastatin	NuCare Pharmaceuticals, Inc.	ANDA	Current
67046-450	Lovastatin	Lovastatin	Contract Pharmacy Services-PA	ANDA	Current
67046-451	Lovastatin	Lovastatin	Contract Pharmacy Services-PA	ANDA	Current
67544-106	Lovastatin	Lovastatin	Aphena Pharma Solutions -	ANDA	Current
67544-225	Lovastatin	Lovastatin	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
67544-225	Lovastatin	Lovastatin	Aphena Pharma Solutions -	ANDA	Current
67544-245	Lovastatin	Lovastatin	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
67544-245	Lovastatin	Lovastatin	Aphena Pharma Solutions -	ANDA	Current
68001-214	Lovastatin	Lovastatin	BluePoint Laboratories	ANDA	Current
68001-224	Lovastatin	Lovastatin	BluePoint Laboratories	ANDA	Current
68071-1973	Lovastatin	Lovastatin	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-3397	Lovastatin	Lovastatin	NuCare Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22492	ORIG	2005-07-22