Application 077730

Type: ANDA
Sponsor: PLIVA HRVATSKA DOO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	TABLET;ORAL	10MG	No	No
002	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	TABLET;ORAL	20MG	No	No
003	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	TABLET;ORAL	30MG	No	No
004	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	TABLET; ORAL	80MG	No	No
005	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A077730-001	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	2006-11-21
A077730-002	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	2006-11-21
A077730-003	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	30MG	TABLET / ORAL	2006-11-21
A077730-005	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	2006-11-21

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 5 · 172 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	A077730-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	2006-11-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077730-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	2006-11-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077730-003	PRAVASTATIN SODIUM	30MG	TABLET / ORAL	2006-11-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077730-005	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	2006-11-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077730-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	2006-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077730-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	2006-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077730-003	PRAVASTATIN SODIUM	30MG	TABLET / ORAL	2006-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077730-005	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	2006-11-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077730-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	2006-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077730-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	2006-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077730-003	PRAVASTATIN SODIUM	30MG	TABLET / ORAL	2006-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077730-005	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	2006-11-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077730-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	2006-11-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077730-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	2006-11-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077730-003	PRAVASTATIN SODIUM	30MG	TABLET / ORAL	2006-11-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077730-005	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	2006-11-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077730-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	2006-11-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077730-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	2006-11-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077730-003	PRAVASTATIN SODIUM	30MG	TABLET / ORAL	2006-11-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077730-005	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	2006-11-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077730-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	2006-11-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077730-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	2006-11-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077730-003	PRAVASTATIN SODIUM	30MG	TABLET / ORAL	2006-11-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077730-005	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	2006-11-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077730-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	2006-11-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077730-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	2006-11-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077730-003	PRAVASTATIN SODIUM	30MG	TABLET / ORAL	2006-11-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077730-005	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	2006-11-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077730-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	2006-11-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077730-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	2006-11-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077730-003	PRAVASTATIN SODIUM	30MG	TABLET / ORAL	2006-11-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077730-005	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	2006-11-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077730-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	2006-11-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077730-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	2006-11-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077730-003	PRAVASTATIN SODIUM	30MG	TABLET / ORAL	2006-11-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077730-005	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	2006-11-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077730-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	2006-11-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077730-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	2006-11-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077730-003	PRAVASTATIN SODIUM	30MG	TABLET / ORAL	2006-11-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077730-005	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	2006-11-21	`5bbf6a4d5a75…`

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 7 · 121 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pravastatin sodium	PRAVASTATIN SODIUM	REMEDYREPACK INC.	6cef5e92-26b7-435c-878f-72a05a624560	2026-09-10	Warnings, Adverse reactions	Name fallback brand name: Pravastatin sodium generic name: PRAVASTATIN SODIUM
Pravastatin sodium	PRAVASTATIN SODIUM	REMEDYREPACK INC.	fa152ce7-6c07-4aaf-9374-932ce81d0cf9	2026-09-04	Warnings, Adverse reactions	Name fallback brand name: Pravastatin sodium generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	CIPLA USA INC.	678dfe58-3200-4c3d-9718-365aa47d070f	2026-09-03	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	REMEDYREPACK INC.	5ecd9fd1-7662-412d-99c5-13c77188748c	2026-08-21	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	REMEDYREPACK INC.	e4dbaa72-7b3e-4aef-983b-90efb2b343cd	2026-08-21	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Preferred Pharmaceuticals Inc.	6d42bd30-1f09-49f4-9ec8-31366df1b4b4	2026-08-17	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Preferred Pharmaceuticals Inc.	46cdd32d-a022-4acf-ba2b-10e7877d56c6	2026-08-17	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Preferred Pharmaceuticals Inc..	ebd794ba-90c3-4d81-9c45-4aa9d9454359	2026-08-17	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
Pravastatin Sodium	PRAVASTATIN SODIUM	Preferred Pharmaceuticals Inc.	095ac6fd-fdfb-4207-b15d-8e93bee378c3	2026-08-17	Warnings, Adverse reactions	Name fallback brand name: Pravastatin Sodium generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Cardinal Health 107, LLC	3e218ad6-5b47-4cca-81be-ebaea5795964	2026-08-13	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Quallent	e9c188f7-cd6f-afac-b493-36552d86589e	2026-08-03	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Apotex Corp.	dcf45e4f-b46e-6fbb-b67a-2ff619ab1780	2026-07-31	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
Pravastatin sodium	PRAVASTATIN SODIUM	Aurobindo Pharma Limited	b06ed801-ddee-4f56-924a-59fcb451eae6	2026-07-29	Warnings, Adverse reactions	Name fallback brand name: Pravastatin sodium generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	PD-Rx Pharmaceuticals, Inc.	c5f611aa-9974-422e-a353-5d834a33937c	2026-07-07	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	PD-Rx Pharmaceuticals, Inc.	8dbdc80d-9d8c-4e22-9108-d87a77e07a6b	2026-07-07	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
Pravastatin sodium	PRAVASTATIN SODIUM	Safecor Health LLC	0ae196a4-be3d-4cd8-9ff2-68aeb91b8678	2026-07-01	Warnings, Adverse reactions	Name fallback brand name: Pravastatin sodium generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	American Health Packaging	97f826f0-b5c5-410c-b1f0-523873981e8d	2026-06-17	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ca7a4143-0091-4cd5-9061-cb05cc84ea4e	2026-06-16	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
Pravastatin sodium	PRAVASTATIN SODIUM	Bryant Ranch Prepack	f074240e-ef6b-45f2-8c4d-cb5c0dbc81f1	2026-06-11	Warnings, Adverse reactions	Name fallback brand name: Pravastatin sodium generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Cardinal Health 107, LLC	9289f9ed-b6e3-4e81-bdb8-6aedbd5288a9	2026-06-11	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM

Reported adverse events (FAERS/openFDA)#

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