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 2 of 3 · 56 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lovastatin	LOVASTATIN	A-S Medication Solutions	dd7a223e-7fc5-4eb0-9bd7-2f9a2d6b4173	2025-10-10	Warnings, Adverse reactions	Name fallback brand name: Lovastatin generic name: LOVASTATIN
Lovastatin	LOVASTATIN	A-S Medication Solutions	bfb889a4-5751-4706-9fa7-f48672c1bc08	2025-10-10	Warnings, Adverse reactions	Name fallback brand name: Lovastatin generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Bryant Ranch Prepack	220a9b3c-c583-49e3-8bf0-d0c97dc9b829	2025-04-01	Warnings, Adverse reactions	Name fallback brand name: Lovastatin generic name: LOVASTATIN
Lovastatin	LOVASTATIN	PD-Rx Pharmaceuticals, Inc.	c37206ae-52f1-4192-9ab9-3044247cf58d	2025-03-13	Warnings, Adverse reactions	Name fallback brand name: Lovastatin generic name: LOVASTATIN
Lovastatin	LOVASTATIN	PD-Rx Pharmaceuticals, Inc.	ac86821f-d741-4ab1-bd03-ce8797dd4f34	2025-03-12	Warnings, Adverse reactions	Name fallback brand name: Lovastatin generic name: LOVASTATIN
Lovastatin	LOVASTATIN	PD-Rx Pharmaceuticals, Inc.	70e2bf86-4a78-4dfb-b6b1-8eb95f63684d	2025-03-06	Warnings, Adverse reactions	Name fallback brand name: Lovastatin generic name: LOVASTATIN
Lovastatin	LOVASTATIN	PD-Rx Pharmaceuticals, Inc.	eea93a4b-f804-4b9c-aabf-e906f03c1e80	2025-02-28	Warnings, Adverse reactions	Name fallback brand name: Lovastatin generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Boswell Pharmacy Services LLC d/b/a BPS Wholesale	2eff3e5e-8746-048e-e063-6294a90a38c4	2025-02-25	Warnings, Adverse reactions	Name fallback brand name: Lovastatin generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Boswell Pharmacy Services LLC d/b/a BPS Wholesale	2eeb34ac-f973-e7d9-e063-6294a90a076e	2025-02-24	Warnings, Adverse reactions	Name fallback brand name: Lovastatin generic name: LOVASTATIN
Lovastatin	LOVASTATIN	NuCare Pharmaceuticals, Inc.	50217921-97a7-6ff2-e054-00144ff88e88	2025-02-04	Warnings, Adverse reactions	Name fallback brand name: Lovastatin generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Carlsbad Technology, Inc.	0a680e13-0356-4e08-a7fe-78b96ba51b9d	2025-01-07	Warnings, Adverse reactions	Name fallback brand name: Lovastatin generic name: LOVASTATIN
Lovastatin	LOVASTATIN	A-S Medication Solutions	4ff981e8-5c86-4b86-baa1-825551905ed8	2024-12-12	Warnings, Adverse reactions	Name fallback brand name: Lovastatin generic name: LOVASTATIN
Lovastatin	LOVASTATIN	A-S Medication Solutions	02aae38d-ee9d-4c09-a155-b69f221ed3e9	2024-10-15	Warnings, Adverse reactions	Name fallback brand name: Lovastatin generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Bryant Ranch Prepack	c871a6a7-67a4-4ac1-b102-3f1604625c7d	2024-09-12	Warnings, Adverse reactions	Name fallback brand name: Lovastatin generic name: LOVASTATIN
Lovastatin	LOVASTATIN	NuCare Pharmaceuticals, Inc.	415c2698-7787-49f8-e054-00144ff88e88	2024-08-14	Warnings, Adverse reactions	Name fallback brand name: Lovastatin generic name: LOVASTATIN
Lovastatin	LOVASTATIN	NuCare Pharmaceuticals, Inc.	4444573e-9df1-01e6-e054-00144ff8d46c	2024-08-14	Warnings, Adverse reactions	Name fallback brand name: Lovastatin generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Bryant Ranch Prepack	8d8199ca-df39-4eb8-a905-dee3ab7e2973	2024-08-14	Warnings, Adverse reactions	Name fallback brand name: Lovastatin generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Bryant Ranch Prepack	5684ceb8-a5b2-4fb4-92be-14aabcea3871	2024-08-09	Warnings, Adverse reactions	Name fallback brand name: Lovastatin generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Bryant Ranch Prepack	ad905651-6e3a-4140-aa37-d91e5f37c0f0	2024-08-08	Warnings, Adverse reactions	Name fallback brand name: Lovastatin generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Bryant Ranch Prepack	a623c1da-e94e-41be-900c-9e74376d36c8	2024-08-08	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.