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 5 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	Aurobindo Pharma Limited	c21d4797-d252-4073-891f-330484c5f643	2025-02-18	Warnings, Adverse reactions	Name fallback brand name: Pravastatin sodium generic name: PRAVASTATIN SODIUM
Pravastatin sodium	PRAVASTATIN SODIUM	Aurobindo Pharma Limited	cf6f7031-33b9-40d3-bc87-32f1b6af98f2	2025-02-18	Warnings, Adverse reactions	Name fallback brand name: Pravastatin sodium generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Aphena Pharma Solutions - Tennessee, LLC	2e5c8a1c-b36f-d124-e063-6394a90a6fb5	2025-02-17	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Aphena Pharma Solutions - Tennessee, LLC	2e5cfae8-20b8-1fea-e063-6394a90a4e17	2025-02-17	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Coupler LLC	2e0655ba-b1ba-789b-e063-6294a90a0a19	2025-02-13	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Coupler LLC	2e07ad78-1059-e0ec-e063-6394a90a9bff	2025-02-13	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
Pravastatin Sodium	PRAVASTATIN SODIUM	NuCare Pharmaceuticals, Inc.	2d40e473-f79a-e50e-e063-6294a90a4d9e	2025-02-03	Warnings, Adverse reactions	Name fallback brand name: Pravastatin Sodium generic name: PRAVASTATIN SODIUM
Pravastatin Sodium	PRAVASTATIN SODIUM	Chartwell RX, LLC	f87016fb-4c01-4279-8cf7-59819971ca15	2025-01-30	Warnings, Adverse reactions	Name fallback brand name: Pravastatin Sodium generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	7b900a28-f20e-49d5-98a9-5513fee0a901	2025-01-30	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	DIRECT RX	97178675-3691-2d93-e053-2995a90aa5c1	2025-01-17	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
Pravastatin Sodium	PRAVASTATIN SODIUM	Quality Care Products, LLC	465dc828-966e-4bb4-b935-ef26583dd4e6	2024-12-19	Warnings, Adverse reactions	Name fallback brand name: Pravastatin Sodium generic name: PRAVASTATIN SODIUM
Pravastatin Sodium	PRAVASTATIN SODIUM	Lake Erie Medical DBA Quality Care Products LLC	e7194af1-6304-4e3e-88ab-0825706a3962	2024-12-11	Warnings, Adverse reactions	Name fallback brand name: Pravastatin Sodium generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	NCS HealthCare of KY, LLC dba Vangard Labs	27ba8a69-b5aa-40eb-89f7-6bf2c1fcceae	2024-12-06	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
Pravastatin Sodium	PRAVASTATIN SODIUM	A-S Medication Solutions	55f8cf43-bf8b-4729-9e5a-32fcc9696e02	2024-10-30	Warnings, Adverse reactions	Name fallback brand name: Pravastatin Sodium generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	A-S Medication Solutions	7b4ef7a8-47e5-428f-91de-7307dcbb9167	2024-10-23	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	6bb60d07-0787-4d5f-8a8c-1224d5b02b2b	2024-08-30	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	06d85243-f9df-4984-b3d3-fcd8a7c554e9	2024-08-20	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	01beb7e2-ba01-4f2f-8554-4a8ec0941c9f	2024-08-14	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	NuCare Pharmaceuticals, Inc.	54228087-7ab0-5561-e054-00144ff8d46c	2024-07-10	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	NuCare Pharmaceuticals,Inc.	548bdd9f-dcc6-28c7-e054-00144ff8d46c	2024-07-10	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