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 6 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	NuCare Pharmaceuticals,Inc.	8e9d5896-0b7c-dbd4-e053-2a95a90ae2f6	2024-06-18	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	NuCare Pharmaceuticals,Inc.	8ed7879d-988c-1a27-e053-2995a90a0361	2024-06-18	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	73633a65-93b9-46dd-8f9f-d4b5c0089040	2024-06-05	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	24471777-5cd6-4c46-a5f2-a349fadc830e	2024-04-04	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
Pravastatin Sodium	PRAVASTATIN SODIUM	Direct_Rx	7f814fd9-7b35-67da-e053-2a91aa0a39dc	2024-01-10	Warnings, Adverse reactions	Name fallback brand name: Pravastatin Sodium generic name: PRAVASTATIN SODIUM
Pravastatin Sodium	PRAVASTATIN SODIUM	Teva Pharmaceuticals USA, Inc.	99e0e848-f8f3-4b42-b880-8fbc42633948	2024-01-01	Warnings, Adverse reactions	Name fallback brand name: Pravastatin Sodium generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Lupin Pharmaceuticals, Inc.	1123d56c-16f0-4f81-b56f-67b1f343ae1e	2023-12-19	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
Pravastatin Sodium	PRAVASTATIN SODIUM	A-S Medication Solutions	4f9ada33-5592-4780-926d-1af49a8e064e	2023-12-15	Warnings, Adverse reactions	Name fallback brand name: Pravastatin Sodium generic name: PRAVASTATIN SODIUM
Pravastatin Sodium	PRAVASTATIN SODIUM	A-S Medication Solutions	a75de063-c751-4647-bb9e-d4050c1e31fc	2023-12-14	Warnings, Adverse reactions	Name fallback brand name: Pravastatin Sodium generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	70920620-37d6-4fe0-9d86-1fdffc2e6a99	2023-10-25	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Proficient Rx LP	4d2b4607-0a46-4b58-9247-dc448ce258ec	2023-08-01	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
Pravastatin Sodium	PRAVASTATIN SODIUM	Proficient Rx LP	466e2d1a-a6d6-40f8-a9f6-3e7494a34ca6	2023-08-01	Warnings, Adverse reactions	Name fallback brand name: Pravastatin Sodium generic name: PRAVASTATIN SODIUM
Pravastatin Sodium	PRAVASTATIN SODIUM	NorthStar RxLLC	ce15ad07-3286-478f-9f30-1db6a45ed402	2023-03-03	Warnings, Adverse reactions	Name fallback brand name: Pravastatin Sodium generic name: PRAVASTATIN SODIUM
Pravastatin Sodium	PRAVASTATIN SODIUM	A-S Medication Solutions	4948e795-8c33-40e2-ae85-208962daee72	2023-02-06	Warnings, Adverse reactions	Name fallback brand name: Pravastatin Sodium generic name: PRAVASTATIN SODIUM
Pravastatin Sodium	PRAVASTATIN SODIUM	A-S Medication Solutions	3a08fa97-24c3-4a4a-a0aa-26e50cbfc52d	2023-02-06	Warnings, Adverse reactions	Name fallback brand name: Pravastatin Sodium generic name: PRAVASTATIN SODIUM
Pravastatin Sodium	PRAVASTATIN SODIUM	Glenmark Pharmaceuticals Inc., USA	6ca01de3-a0f9-4cfb-b36a-723c7c42e2a4	2022-07-08	Warnings, Adverse reactions	Name fallback brand name: Pravastatin Sodium generic name: PRAVASTATIN SODIUM
Pravastatin Sodium	PRAVASTATIN SODIUM	Teva Pharmaceuticals, Inc.	f66cb1c1-5ff1-4b0b-89d0-8ecaee26b0b8	2022-07-01	Warnings, Adverse reactions	Name fallback brand name: Pravastatin Sodium generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Aphena Pharma Solutions - Tennessee, LLC	ce61f570-2564-429b-8775-157e8e32d378	2022-03-03	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Proficient Rx LP	2bdfb0ef-2455-4ca2-a117-ce8e26bb2dbc	2022-03-01	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Proficient Rx LP	63ca6179-6ae3-4f0b-bdca-50d200317921	2019-10-01	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