Application 075551

Type: ANDA
Sponsor: TEVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LOVASTATIN	LOVASTATIN	TABLET;ORAL	40MG	No	No
002	LOVASTATIN	LOVASTATIN	TABLET;ORAL	20MG	No	No
003	LOVASTATIN	LOVASTATIN	TABLET;ORAL	10MG	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
A075551-001	LOVASTATIN	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17
A075551-002	LOVASTATIN	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17
A075551-003	LOVASTATIN	LOVASTATIN	10MG	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
A075551-001	AB
A075551-002	AB
A075551-003	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	A075551-001	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075551-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075551-003	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075551-001	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075551-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075551-003	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075551-001	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075551-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075551-003	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075551-001	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075551-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075551-003	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075551-001	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075551-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075551-003	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075551-001	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075551-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075551-003	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075551-001	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075551-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075551-003	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075551-001	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075551-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075551-003	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075551-001	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075551-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075551-003	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075551-001	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075551-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075551-003	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075551-001	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075551-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075551-003	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075551-001	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075551-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075551-003	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075551-001	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075551-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075551-003	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075551-001	LOVASTATIN	40MG	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	A075551-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075551-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075551-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075551-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075551-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075551-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075551-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075551-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075551-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075551-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075551-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075551-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075551-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075551-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075551-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075551-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075551-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075551-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075551-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075551-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075551-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075551-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075551-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075551-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075551-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075551-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075551-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075551-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075551-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075551-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075551-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075551-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075551-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075551-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075551-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075551-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075551-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075551-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075551-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075551-001	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 1 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lovastatin	LOVASTATIN	REMEDYREPACK INC.	a902a95f-072a-4487-99a9-109a93f8b23c	2026-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075551 application number: ANDA075551 ndc (product): 70518-3064
Lovastatin	LOVASTATIN	Golden State Medical Supply, Inc.	91332c54-1a27-4e6b-e053-2a95a90a42cd	2025-12-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075551 application number: ANDA075551 ndc (product): 51407-251 ndc (product): 51407-253 ndc (product): 51407-252
Lovastatin	LOVASTATIN	A-S Medication Solutions	4ff981e8-5c86-4b86-baa1-825551905ed8	2024-12-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075551 application number: ANDA075551 ndc (product): 50090-3216 ndc (product): 50090-3268
Lovastatin	LOVASTATIN	Bryant Ranch Prepack	ad905651-6e3a-4140-aa37-d91e5f37c0f0	2024-08-08	Warnings, Adverse reactions	Exact identifier ndc (product): 63629-1464
Lovastatin	LOVASTATIN	Aphena Pharma Solutions - Tennessee, LLC	7e96b174-3887-4908-9b9f-5ef93540f96a	2023-05-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075551 application number: ANDA075551
Lovastatin	LOVASTATIN	Teva Pharmaceuticals USA, Inc.	0e15feec-d27e-4861-8152-c5a8b8ccacd4	2020-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075551 application number: ANDA075551 ndc (product): 0093-0926 ndc (product): 0093-0576 ndc (product): 0093-0928
Lovastatin	LOVASTATIN	Proficient Rx LP	027bd594-6a0a-4e6d-bd3c-4f33fdb4166a	2020-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075551 application number: ANDA075551 ndc (product): 71205-440

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 56 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-0576	Lovastatin	Lovastatin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0576	Lovastatin	Lovastatin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0576	Lovastatin	Lovastatin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0576	Lovastatin	Lovastatin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0576	Lovastatin	Lovastatin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0576	Lovastatin	Lovastatin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0926	Lovastatin	Lovastatin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0926	Lovastatin	Lovastatin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0926	Lovastatin	Lovastatin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0926	Lovastatin	Lovastatin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0926	Lovastatin	Lovastatin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0926	Lovastatin	Lovastatin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0928	Lovastatin	Lovastatin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0928	Lovastatin	Lovastatin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0928	Lovastatin	Lovastatin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0928	Lovastatin	Lovastatin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0928	Lovastatin	Lovastatin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0928	Lovastatin	Lovastatin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
50090-3216	Lovastatin	Lovastatin	A-S Medication Solutions	ANDA	Current
50090-3216	Lovastatin	Lovastatin	A-S Medication Solutions	ANDA	Current
50090-3216	Lovastatin	Lovastatin	A-S Medication Solutions	ANDA	Current
50090-3268	Lovastatin	Lovastatin	A-S Medication Solutions	ANDA	Current
51407-251	Lovastatin	Lovastatin	Golden State Medical Supply Inc.	ANDA	Current
51407-251	Lovastatin	Lovastatin	Golden State Medical Supply	ANDA	Current
51407-251	Lovastatin	Lovastatin	Golden State Medical Supply	ANDA	Current
51407-251	Lovastatin	Lovastatin	Golden State Medical Supply	ANDA	Current
51407-252	Lovastatin	Lovastatin	Golden State Medical Supply Inc.	ANDA	Current
51407-252	Lovastatin	Lovastatin	Golden State Medical Supply	ANDA	Current
51407-252	Lovastatin	Lovastatin	Golden State Medical Supply	ANDA	Current
51407-252	Lovastatin	Lovastatin	Golden State Medical Supply	ANDA	Current
51407-253	Lovastatin	Lovastatin	Golden State Medical Supply Inc.	ANDA	Current
51407-253	Lovastatin	Lovastatin	Golden State Medical Supply	ANDA	Current
51407-253	Lovastatin	Lovastatin	Golden State Medical Supply	ANDA	Current
51407-253	Lovastatin	Lovastatin	Golden State Medical Supply	ANDA	Current
53002-5701	Lovastatin	Lovastatin	RPK Pharmaceuticals, Inc.	ANDA	Current
54458-844	LOVASTATIN	LOVASTATIN	International Laboratories, LLC	ANDA	Current
54458-844	LOVASTATIN	LOVASTATIN	International Laboratories, LLC	ANDA	Current
54458-845	LOVASTATIN	LOVASTATIN	International Laboratories, LLC	ANDA	Current
54458-845	LOVASTATIN	LOVASTATIN	International Laboratories, LLC	ANDA	Current
54458-846	LOVASTATIN	LOVASTATIN	International Laboratories, LLC	ANDA	Current
54458-846	LOVASTATIN	LOVASTATIN	International Laboratories, LLC	ANDA	Current
54458-870	Lovastatin	Lovastatin	International Laboratories, LLC	ANDA	Current
54458-870	Lovastatin	Lovastatin	International Laboratories, LLC	ANDA	Current
54458-871	Lovastatin	Lovastatin	International Laboratories, LLC	ANDA	Current
54458-871	Lovastatin	Lovastatin	International Laboratories, LLC	ANDA	Current
54458-914	LOVASTATIN	LOVASTATIN	International Laboratories, LLC	ANDA	Current
54458-915	LOVASTATIN	LOVASTATIN	International Laboratories, LLC	ANDA	Current
54458-916	LOVASTATIN	LOVASTATIN	International Laboratories, LLC	ANDA	Current
63629-1464	Lovastatin	Lovastatin	Bryant Ranch Prepack	ANDA	Current
68071-2653	Lovastatin	Lovastatin	NuCare Pharmaceuticals,Inc.	ANDA	Current
70518-3064	Lovastatin	Lovastatin	REMEDYREPACK INC.	ANDA	Current
70518-3064	Lovastatin	Lovastatin	REMEDYREPACK INC.	ANDA	Current
70934-750	Lovastatin	Lovastatin	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
70934-755	Lovastatin	Lovastatin	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
71205-440	Lovastatin	Lovastatin	Proficient Rx LP	ANDA	Current
71610-396	Lovastatin	Lovastatin	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
43002	ORIG	2005-07-22