Application 076445

Type: ANDA
Sponsor: RANBAXY LABS LTD

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	40MG	No	No
004	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	TABLET;ORAL	80MG	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
A076445-001	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	2007-04-23
A076445-002	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	2007-04-23
A076445-003	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	2007-04-23
A076445-004	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	2007-04-23

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	A076445-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	2007-04-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076445-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	2007-04-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076445-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	2007-04-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076445-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	2007-04-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076445-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	2007-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076445-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	2007-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076445-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	2007-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076445-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	2007-04-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076445-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	2007-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076445-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	2007-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076445-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	2007-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076445-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	2007-04-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076445-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	2007-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076445-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	2007-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076445-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	2007-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076445-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	2007-04-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076445-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	2007-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076445-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	2007-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076445-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	2007-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076445-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	2007-04-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076445-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	2007-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076445-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	2007-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076445-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	2007-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076445-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	2007-04-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076445-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	2007-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076445-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	2007-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076445-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	2007-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076445-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	2007-04-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076445-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	2007-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076445-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	2007-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076445-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	2007-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076445-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	2007-04-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076445-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	2007-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076445-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	2007-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076445-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	2007-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076445-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	2007-04-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076445-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	2007-04-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076445-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	2007-04-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076445-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	2007-04-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076445-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	2007-04-23	`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 3 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	Bryant Ranch Prepack	c0b1b483-1a19-4966-89b1-118ec660f203	2026-01-29	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	AvPAK	ba4ac602-46fa-8386-e053-2995a90a9764	2026-01-09	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	A-S Medication Solutions	3e6d1c1e-d5f7-42ec-bcdd-8fc310acdf21	2026-01-06	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
Pravastatin sodium	PRAVASTATIN SODIUM	Northwind Health Company, LLC	40aa2d36-57ce-1f48-e063-6294a90affef	2026-01-02	Warnings, Adverse reactions	Name fallback brand name: Pravastatin sodium generic name: PRAVASTATIN SODIUM
Pravastatin Sodium	PRAVASTATIN SODIUM	Northwind Health Company, LLC	f6ddb6c0-d0b4-2297-e053-6294a90a83c9	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Pravastatin Sodium generic name: PRAVASTATIN SODIUM
Pravastatin Sodium	PRAVASTATIN SODIUM	Northwind Health Company, LLC	db0e9c21-dc25-629a-e053-2a95a90a5ac3	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Pravastatin Sodium generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Northwind Health Company, LLC	db5b8821-dca8-9322-e053-2a95a90abdc3	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Northwind Health Company, LLC	df75b04e-3e85-9705-e053-2995a90af83f	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
Pravastatin sodium	PRAVASTATIN SODIUM	Northwind Health Company, LLC	47207487-0c6d-8da3-e063-6294a90a8aee	2025-12-29	Warnings, Adverse reactions	Name fallback brand name: Pravastatin sodium generic name: PRAVASTATIN SODIUM
Pravastatin sodium	PRAVASTATIN SODIUM	Northwind Health Company, LLC	471b4dac-057d-740c-e063-6294a90af9e9	2025-12-19	Warnings, Adverse reactions	Name fallback brand name: Pravastatin sodium generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	A-S Medication Solutions	fd76794d-de33-4886-875c-fa05b2639f84	2025-12-10	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Coupler LLC	4573c42b-6d4a-e001-e063-6294a90acea1	2025-12-08	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
Pravastatin sodium	PRAVASTATIN SODIUM	Preferred Pharmaceuticals Inc.	f92e12bc-40c3-4afa-9190-2f4de11ec6b3	2025-12-08	Warnings, Adverse reactions	Name fallback brand name: Pravastatin sodium generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	12943de2-c7e9-4651-89f3-fc6cb5276676	2025-11-17	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	97123f09-b5ad-45c2-8bb7-f50566b56b08	2025-11-17	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	2ba7af14-9c87-4eb0-84c9-7e895cd75fae	2025-11-14	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Accord Healthcare Inc.	6c011348-a236-47d3-bbef-3e0b956dd080	2025-11-14	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
Pravastatin sodium	PRAVASTATIN SODIUM	Bryant Ranch Prepack	4ed7a4d1-1183-4d95-8311-6d3e58feafa8	2025-11-10	Warnings, Adverse reactions	Name fallback brand name: Pravastatin sodium generic name: PRAVASTATIN SODIUM
Pravastatin sodium	PRAVASTATIN SODIUM	Bryant Ranch Prepack	91c5b5c8-3379-4b84-aff7-ef6cfc65fe9f	2025-11-10	Warnings, Adverse reactions	Name fallback brand name: Pravastatin sodium generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	abcfc343-7ac9-4fce-b368-fd05cf14b0e2	2025-11-04	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.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31123	ORIG	2007-05-01