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 4 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	Preferred Pharmaceuticals Inc.	e6a3d99c-c9cc-49d9-b0f9-503770307b70	2025-10-31	Warnings, Adverse reactions	Name fallback brand name: Pravastatin sodium generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	03e27551-b3bf-47dd-b3ec-cd9a66ace3c4	2025-10-30	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
Pravastatin sodium	PRAVASTATIN SODIUM	NuCare Pharmaceuticals, Inc.	3ef390a6-e0a0-331d-e063-6394a90a83d0	2025-10-27	Warnings, Adverse reactions	Name fallback brand name: Pravastatin sodium generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	A-S Medication Solutions	45f0fd53-7160-4361-ba0b-3401095441c4	2025-10-15	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	A-S Medication Solutions	635062df-9a84-4ff8-874c-dcee581a5555	2025-10-15	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
Pravastatin sodium	PRAVASTATIN SODIUM	A-S Medication Solutions	33c141e9-76dc-4e32-9b2a-4621f32ac4bd	2025-07-24	Warnings, Adverse reactions	Name fallback brand name: Pravastatin sodium generic name: PRAVASTATIN SODIUM
Pravastatin sodium	PRAVASTATIN SODIUM	A-S Medication Solutions	72693449-01ee-42b0-9902-566252324579	2025-07-24	Warnings, Adverse reactions	Name fallback brand name: Pravastatin sodium generic name: PRAVASTATIN SODIUM
Pravastatin Sodium	PRAVASTATIN SODIUM	A-S Medication Solutions	4015f184-b57e-4d32-9cef-15c6e1cefe24	2025-05-28	Warnings, Adverse reactions	Name fallback brand name: Pravastatin Sodium generic name: PRAVASTATIN SODIUM
Pravastatin Sodium	PRAVASTATIN SODIUM	A-S Medication Solutions	b7a84cc1-f6e4-40be-9e68-cf7d43bbd617	2025-05-28	Warnings, Adverse reactions	Name fallback brand name: Pravastatin Sodium generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	7b7f5c28-78fa-4625-ad69-4291500e033d	2025-05-19	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	51800012-406b-4389-817f-88dd21e338d1	2025-05-19	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	a7f75948-2958-44c8-b52f-5e39e80cdd1f	2025-05-13	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
Pravastatin Sodium	PRAVASTATIN SODIUM	A-S Medication Solutions	bdf02140-3647-498e-ba0a-f4ca920b4e90	2025-05-01	Warnings, Adverse reactions	Name fallback brand name: Pravastatin Sodium generic name: PRAVASTATIN SODIUM
Pravastatin Sodium	PRAVASTATIN SODIUM	Preferred Pharmaceuticals Inc.	7abc1825-182d-40bc-9f7f-968e197b4246	2025-04-30	Warnings, Adverse reactions	Name fallback brand name: Pravastatin Sodium generic name: PRAVASTATIN SODIUM
Pravastatin Sodium	PRAVASTATIN SODIUM	A-S Medication Solutions	88e3b5b1-8379-492b-8902-af77f87ad995	2025-04-25	Warnings, Adverse reactions	Name fallback brand name: Pravastatin Sodium generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	e358f314-9cbe-46a4-9564-6bedc7ef9d59	2025-04-23	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	80ddec55-6a18-4b87-8a07-6ae86ad62853	2025-04-23	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	2290cad1-55c3-45a0-9d50-dd149678d191	2025-04-22	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	0bb2f1e8-9405-4f06-9a33-5ba06765a8e7	2025-04-22	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Aphena Pharma Solutions - Tennessee, LLC	308db0cc-0deb-99b6-e063-6394a90a9b74	2025-03-17	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