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 1.

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 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
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…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076445-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	2007-04-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076445-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	2007-04-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076445-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	2007-04-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076445-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	2007-04-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076445-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	2007-04-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076445-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	2007-04-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076445-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	2007-04-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076445-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	2007-04-23	`d06236e962d9…`

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 · 127 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pravastatin Sodium	PRAVASTATIN SODIUM	REMEDYREPACK INC.	0c4b59f1-92a8-44f8-8b4c-691f35777460	2026-07-30	Warnings, Adverse reactions	Name fallback brand name: Pravastatin Sodium generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	REMEDYREPACK INC.	e4dbaa72-7b3e-4aef-983b-90efb2b343cd	2026-07-16	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
Pravastatin Sodium	PRAVASTATIN SODIUM	Cardinal Health 107, LLC	ca779f66-4b9d-41da-ad0e-e4f58db9fbac	2026-07-10	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	REMEDYREPACK INC.	5ecd9fd1-7662-412d-99c5-13c77188748c	2026-07-01	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	REMEDYREPACK INC.	76e5fdf8-bd03-4cd5-9361-e61678cb3de9	2026-06-26	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	2026-06-26	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
Pravastatin sodium	PRAVASTATIN SODIUM	Bryant Ranch Prepack	3686a2df-51c4-4f1c-9d1e-d69207915144	2026-06-11	Warnings, Adverse reactions	Name fallback brand name: Pravastatin sodium generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	14390bfa-3bcb-43e1-936c-1977cb37427d	2026-06-04	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	8d1bf7a5-bf11-47e3-afca-dcc13f2d3068	2026-06-04	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	d0641def-425e-4357-a6b6-24ce00424549	2026-06-01	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	dcf46d0c-87da-4009-b238-eb5cf287c3ed	2026-05-29	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	PD-Rx Pharmaceuticals, Inc.	2ded7e5e-c377-4495-a045-f1c57b90c5db	2026-05-21	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	PD-Rx Pharmaceuticals, Inc.	46fdf929-c961-4dd9-8865-8eb4adaa259a	2026-05-21	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM

Documents#

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