Application 077917

Type: ANDA
Sponsor: LUPIN PHARMS

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	TE codes	Approval date
A077917-001	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2008-01-08
A077917-002	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2008-01-08
A077917-003	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2008-01-08
A077917-004	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2008-01-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077917-001	AB
A077917-002	AB
A077917-003	AB
A077917-004	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 · 164 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
2026-02-19 14:30 UTC	2026-02	A077917-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2008-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077917-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2008-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077917-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2008-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077917-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2008-01-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077917-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2008-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077917-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2008-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077917-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2008-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077917-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2008-01-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077917-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2008-01-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077917-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2008-01-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077917-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2008-01-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077917-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2008-01-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077917-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2008-01-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077917-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2008-01-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077917-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2008-01-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077917-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2008-01-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077917-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2008-01-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077917-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2008-01-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077917-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2008-01-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077917-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2008-01-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077917-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2008-01-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077917-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2008-01-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077917-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2008-01-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077917-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2008-01-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077917-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2008-01-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077917-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2008-01-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077917-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2008-01-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077917-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2008-01-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077917-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2008-01-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077917-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2008-01-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077917-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2008-01-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077917-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2008-01-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077917-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2008-01-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077917-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2008-01-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077917-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2008-01-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077917-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2008-01-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077917-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2008-01-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077917-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2008-01-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077917-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2008-01-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077917-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2008-01-08	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077917-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077917-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077917-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077917-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077917-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077917-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077917-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077917-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077917-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077917-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077917-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077917-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077917-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077917-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077917-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077917-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077917-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077917-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077917-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077917-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077917-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077917-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077917-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077917-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077917-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077917-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077917-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077917-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077917-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077917-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077917-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077917-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077917-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077917-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077917-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077917-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077917-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077917-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077917-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077917-004	AB	1	`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 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pravastatin Sodium	PRAVASTATIN SODIUM	Chartwell RX, LLC	f87016fb-4c01-4279-8cf7-59819971ca15	2025-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077917 application number: ANDA077917
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	24471777-5cd6-4c46-a5f2-a349fadc830e	2024-04-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077917 application number: ANDA077917 ndc (product): 71335-0947
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Lupin Pharmaceuticals, Inc.	1123d56c-16f0-4f81-b56f-67b1f343ae1e	2023-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077917 application number: ANDA077917 ndc (product): 68180-487 ndc (product): 68180-486 ndc (product): 68180-488 ndc (product): 68180-485

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68180-485	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-485	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-485	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-485	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-486	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-486	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-486	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-486	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-487	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-487	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-487	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-487	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-488	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-488	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-488	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-488	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Lupin Pharmaceuticals, Inc.	ANDA	Current
70518-1862	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	REMEDYREPACK INC.	ANDA	Current
70518-1863	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	REMEDYREPACK INC.	ANDA	Current
71335-0947	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
71335-0947	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
71335-0947	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
71335-0947	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current