Application 207068

Type: ANDA
Sponsor: ACCORD HLTHCARE

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	TE codes	Approval date
A207068-001	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2016-11-17
A207068-002	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2016-11-17
A207068-003	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2016-11-17
A207068-004	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2016-11-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A207068-001	AB
A207068-002	AB
A207068-003	AB
A207068-004	AB

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	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A207068-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2016-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207068-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2016-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207068-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2016-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207068-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2016-11-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207068-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2016-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207068-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2016-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207068-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2016-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207068-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2016-11-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207068-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2016-11-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207068-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2016-11-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207068-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2016-11-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207068-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2016-11-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207068-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2016-11-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207068-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2016-11-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207068-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2016-11-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207068-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2016-11-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207068-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2016-11-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207068-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2016-11-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207068-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2016-11-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207068-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2016-11-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207068-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2016-11-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207068-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2016-11-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207068-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2016-11-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207068-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2016-11-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207068-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2016-11-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207068-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2016-11-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207068-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2016-11-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207068-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2016-11-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207068-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2016-11-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207068-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2016-11-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207068-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2016-11-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207068-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2016-11-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207068-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2016-11-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207068-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2016-11-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207068-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2016-11-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207068-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2016-11-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207068-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2016-11-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207068-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2016-11-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207068-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2016-11-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207068-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2016-11-17	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A207068-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207068-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207068-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207068-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207068-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207068-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207068-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207068-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207068-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207068-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207068-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207068-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207068-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207068-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207068-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207068-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207068-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207068-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207068-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207068-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207068-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207068-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207068-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207068-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207068-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207068-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207068-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207068-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207068-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207068-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207068-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207068-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207068-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207068-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207068-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207068-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207068-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207068-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207068-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207068-004	AB	1	`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 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	PD-Rx Pharmaceuticals, Inc.	2ded7e5e-c377-4495-a045-f1c57b90c5db	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207068 application number: ANDA207068
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	PD-Rx Pharmaceuticals, Inc.	46fdf929-c961-4dd9-8865-8eb4adaa259a	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207068 application number: ANDA207068
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	daacdad5-f75d-4f9f-b623-8071f3bef91e	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207068 application number: ANDA207068 ndc (product): 71335-0296
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Accord Healthcare Inc.	6c011348-a236-47d3-bbef-3e0b956dd080	2025-11-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207068 application number: ANDA207068
Pravastatin Sodium	PRAVASTATIN SODIUM	Direct_Rx	7f814fd9-7b35-67da-e053-2a91aa0a39dc	2024-01-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207068 application number: ANDA207068
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Proficient Rx LP	63ca6179-6ae3-4f0b-bdca-50d200317921	2019-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207068 application number: ANDA207068 ndc (product): 71205-121

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 94 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70934-358	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71205-121	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Proficient Rx LP	ANDA	Current
71205-121	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Proficient Rx LP	ANDA	Current
71335-0056	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
71335-0056	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
71335-0056	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
71335-0056	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
71335-0059	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
71335-0059	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
71335-0296	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
71335-0296	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
71335-0296	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
71335-0670	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
71335-0670	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current