Application 077748

Type: ANDA
Sponsor: COREPHARMA

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 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	TE codes	Approval date
A077748-001	LOVASTATIN	LOVASTATIN	10MG	TABLET / ORAL	AB	2007-02-28
A077748-002	LOVASTATIN	LOVASTATIN	20MG	TABLET / ORAL	AB	2007-02-28
A077748-003	LOVASTATIN	LOVASTATIN	40MG	TABLET / ORAL	AB	2007-02-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077748-001	AB
A077748-002	AB
A077748-003	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 · 129 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
2026-09-14 22:38:34	2026-08	A077748-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2007-02-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077748-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2007-02-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077748-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2007-02-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077748-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2007-02-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077748-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2007-02-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077748-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2007-02-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077748-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2007-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077748-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2007-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077748-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2007-02-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077748-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2007-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077748-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2007-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077748-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2007-02-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077748-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2007-02-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077748-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2007-02-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077748-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2007-02-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077748-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2007-02-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077748-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2007-02-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077748-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2007-02-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077748-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2007-02-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077748-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2007-02-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077748-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2007-02-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077748-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2007-02-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077748-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2007-02-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077748-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2007-02-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077748-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2007-02-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077748-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2007-02-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077748-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2007-02-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077748-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2007-02-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077748-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2007-02-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077748-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2007-02-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077748-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2007-02-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077748-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2007-02-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077748-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2007-02-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077748-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2007-02-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077748-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2007-02-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077748-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2007-02-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077748-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2007-02-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077748-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2007-02-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077748-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2007-02-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077748-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2007-02-28	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A077748-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077748-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077748-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077748-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077748-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077748-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077748-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077748-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077748-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077748-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077748-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077748-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077748-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077748-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077748-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077748-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077748-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077748-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077748-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077748-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077748-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077748-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077748-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077748-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077748-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077748-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077748-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077748-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077748-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077748-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077748-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077748-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077748-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077748-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077748-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077748-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077748-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077748-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077748-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077748-001	AB	1	`301d65b070ca…`

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 3 of 3 · 56 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lovastatin	LOVASTATIN	NCS HealthCare of KY, LLC dba Vangard Labs	3af47e72-082d-42ad-bde0-294f8101b45c	2024-08-05	Warnings, Adverse reactions	Name fallback brand name: Lovastatin generic name: LOVASTATIN
Lovastatin	LOVASTATIN	NuCare Pharmaceuticals, Inc.	4aa44b69-2946-2fb1-e054-00144ff8d46c	2024-07-19	Warnings, Adverse reactions	Name fallback brand name: Lovastatin generic name: LOVASTATIN
Lovastatin	LOVASTATIN	NuCare Pharmaceuticals,Inc.	8ccb2a86-cd02-4162-e053-2995a90abe0e	2024-06-18	Warnings, Adverse reactions	Name fallback brand name: Lovastatin generic name: LOVASTATIN
Lovastatin	LOVASTATIN	NuCare Pharmaceuticals,Inc.	19b2bb87-1dc7-cd72-e063-6394a90a0f73	2024-06-18	Warnings, Adverse reactions	Name fallback brand name: Lovastatin generic name: LOVASTATIN
Lovastatin	LOVASTATIN	NuCare Pharmaceuticals,Inc.	1ac7ffb9-860a-fbb6-e063-6294a90a590f	2024-06-13	Warnings, Adverse reactions	Name fallback brand name: Lovastatin generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Aphena Pharma Solutions - Tennessee, LLC	0399c35c-513d-48e6-aa20-e8434e3b18d5	2024-01-23	Warnings, Adverse reactions	Name fallback brand name: Lovastatin generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Aphena Pharma Solutions - Tennessee, LLC	7e96b174-3887-4908-9b9f-5ef93540f96a	2023-05-31	Warnings, Adverse reactions	Name fallback brand name: Lovastatin generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Proficient Rx LP	2b53ab6a-5770-4fd7-9aa1-f4273d4bdaeb	2022-12-01	Warnings, Adverse reactions	Name fallback brand name: Lovastatin generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Proficient Rx LP	eb3b4051-3901-461d-a982-7ecd115ba669	2022-09-01	Warnings, Adverse reactions	Name fallback brand name: Lovastatin generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Proficient Rx LP	da9c25c1-f65c-4dc6-8e13-f727c50fd4e4	2022-09-01	Warnings, Adverse reactions	Name fallback brand name: Lovastatin generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Proficient Rx LP	25efd38a-1495-4824-9137-a3429bc471bd	2022-07-01	Warnings, Adverse reactions	Name fallback brand name: Lovastatin generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Proficient Rx LP	4b512c0b-b2f6-4a16-bee6-7669195497ad	2021-01-04	Warnings, Adverse reactions	Name fallback brand name: Lovastatin generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Proficient Rx LP	c2b1b926-def3-4411-9aed-395b969028fe	2021-01-01	Warnings, Adverse reactions	Name fallback brand name: Lovastatin generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Teva Pharmaceuticals USA, Inc.	0e15feec-d27e-4861-8152-c5a8b8ccacd4	2020-08-01	Warnings, Adverse reactions	Name fallback brand name: Lovastatin generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Proficient Rx LP	027bd594-6a0a-4e6d-bd3c-4f33fdb4166a	2020-04-01	Warnings, Adverse reactions	Name fallback brand name: Lovastatin generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Proficient Rx LP	f9e27117-db98-48bc-b7bc-fc98c9b719cf	2019-11-01	Warnings, Adverse reactions	Name fallback brand name: Lovastatin generic name: LOVASTATIN

Reported adverse events (FAERS/openFDA)#

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