Application 076714

Type: ANDA
Sponsor: DR REDDYS LABS INC

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
A076714-001	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-10-23
A076714-002	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-10-23
A076714-003	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-10-23
A076714-004	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2007-12-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076714-001	AB
A076714-002	AB
A076714-003	AB
A076714-004	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	A076714-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-10-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076714-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-10-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076714-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-10-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076714-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2007-12-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076714-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-10-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076714-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-10-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076714-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-10-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076714-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2007-12-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076714-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-10-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076714-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-10-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076714-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-10-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076714-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2007-12-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076714-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-10-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076714-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-10-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076714-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-10-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076714-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2007-12-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076714-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-10-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076714-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-10-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076714-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-10-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076714-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2007-12-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076714-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-10-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076714-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-10-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076714-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-10-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076714-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2007-12-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076714-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-10-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076714-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-10-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076714-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-10-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076714-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2007-12-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076714-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-10-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076714-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-10-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076714-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-10-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076714-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2007-12-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076714-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-10-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076714-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-10-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076714-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-10-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076714-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2007-12-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076714-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-10-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076714-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-10-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076714-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-10-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076714-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2007-12-28	`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	A076714-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076714-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076714-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076714-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076714-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076714-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076714-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076714-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076714-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076714-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076714-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076714-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076714-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076714-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076714-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076714-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076714-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076714-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076714-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076714-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076714-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076714-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076714-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076714-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076714-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076714-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076714-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076714-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076714-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076714-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076714-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076714-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076714-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076714-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076714-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076714-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076714-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076714-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076714-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076714-004	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pravastatin sodium	PRAVASTATIN SODIUM	Dr.Reddy's Laboratories Limited	99cc0546-bb2d-751e-edfd-1c15a1182e0c	2018-11-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076714 application number: ANDA076714 ndc (product): 55111-229 ndc (product): 55111-230 ndc (product): 55111-274 ndc (product): 55111-231

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-7570	Pravastatin	Pravastatin Sodium	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
43063-143	Pravastatin sodium	Pravastatin sodium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-143	Pravastatin sodium	Pravastatin sodium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-143	Pravastatin sodium	Pravastatin sodium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55111-229	Pravastatin sodium	Pravastatin sodium	Dr.Reddy's Laboratories Limited	ANDA	Current
55111-230	Pravastatin sodium	Pravastatin sodium	Dr.Reddy's Laboratories Limited	ANDA	Current
55111-231	Pravastatin sodium	Pravastatin sodium	Dr.Reddy's Laboratories Limited	ANDA	Current
55111-274	Pravastatin sodium	Pravastatin sodium	Dr.Reddy's Laboratories Limited	ANDA	Current
68788-7193	Pravastatin sodium	Pravastatin sodium	Preferred Pharmaceuticals Inc.	ANDA	Current