Application 077904

Type: ANDA
Sponsor: CIPLA

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
A077904-001	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-10-23
A077904-002	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-10-23
A077904-003	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-10-23
A077904-004	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2016-03-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077904-001	AB
A077904-002	AB
A077904-003	AB
A077904-004	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	A077904-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-10-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077904-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-10-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077904-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-10-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077904-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2016-03-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077904-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-10-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077904-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-10-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077904-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-10-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077904-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2016-03-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077904-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-10-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077904-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-10-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077904-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-10-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077904-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2016-03-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077904-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-10-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077904-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-10-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077904-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-10-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077904-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2016-03-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077904-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-10-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077904-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-10-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077904-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-10-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077904-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2016-03-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077904-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-10-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077904-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-10-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077904-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-10-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077904-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2016-03-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077904-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-10-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077904-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-10-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077904-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-10-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077904-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2016-03-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077904-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-10-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077904-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-10-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077904-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-10-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077904-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2016-03-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077904-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-10-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077904-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-10-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077904-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-10-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077904-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2016-03-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077904-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-10-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077904-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-10-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077904-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-10-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077904-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2016-03-22	`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	A077904-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077904-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077904-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077904-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077904-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077904-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077904-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077904-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077904-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077904-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077904-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077904-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077904-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077904-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077904-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077904-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077904-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077904-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077904-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077904-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077904-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077904-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077904-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077904-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077904-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077904-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077904-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077904-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077904-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077904-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077904-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077904-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077904-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077904-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077904-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077904-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077904-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077904-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077904-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077904-004	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 2 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	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
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	daacdad5-f75d-4f9f-b623-8071f3bef91e	2026-05-19	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
Pravastatin Sodium	PRAVASTATIN SODIUM	Amici Pharma, Inc.	e6551230-fe4c-4a6e-9c19-ae9945b76db0	2026-05-19	Warnings, Adverse reactions	Name fallback brand name: Pravastatin Sodium generic name: PRAVASTATIN SODIUM
Pravastatin sodium	PRAVASTATIN SODIUM	Golden State Medical Supply, Inc.	25b7276e-a69f-af63-e063-6394a90aecf2	2026-04-21	Warnings, Adverse reactions	Name fallback brand name: Pravastatin sodium generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Northwind Health Company, LLC	4fad5d73-aa79-58f2-e063-6294a90af4aa	2026-04-16	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	A-S Medication Solutions	93b0e546-9e0f-40d1-9b1e-082bf16400a4	2026-04-13	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	A-S Medication Solutions	d69e8af8-dbd4-43d9-8e9a-4aed3923a17c	2026-04-13	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
Pravastatin sodium	PRAVASTATIN SODIUM	A-S Medication Solutions	b7f8c679-a602-4268-81b6-962a136a4e43	2026-04-02	Warnings, Adverse reactions	Name fallback brand name: Pravastatin sodium generic name: PRAVASTATIN SODIUM
Pravastatin sodium	PRAVASTATIN SODIUM	A-S Medication Solutions	8df47d82-5b09-414d-99f1-7ac4c77f7c01	2026-04-02	Warnings, Adverse reactions	Name fallback brand name: Pravastatin sodium generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	f4b330ce-dfb0-4e4e-9f37-482458820c66	2026-03-25	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	NCS HealthCare of KY, LLC dba Vangard Labs	64ccb4b5-b77e-4b23-8c74-4685287edb4b	2026-02-27	Warnings, Adverse reactions	Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
Pravastatin sodium	PRAVASTATIN SODIUM	Biocon Pharma Inc.	9bd4a493-1f75-e33a-53fb-4e2fbc64a1eb	2026-02-26	Warnings, Adverse reactions	Name fallback brand name: Pravastatin sodium generic name: PRAVASTATIN SODIUM
Pravastatin sodium	PRAVASTATIN SODIUM	A-S Medication Solutions	2f658680-939a-4212-8a5e-a44a896dd221	2026-02-11	Warnings, Adverse reactions	Name fallback brand name: Pravastatin sodium generic name: PRAVASTATIN SODIUM
Pravastatin sodium	PRAVASTATIN SODIUM	A-S Medication Solutions	3b9fe7c9-791e-49a0-a005-ccf13036c365	2026-02-11	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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69097-183	Pravastatin Sodium	Pravastatin Sodium	Cipla USA Inc.	ANDA	Current
69097-184	Pravastatin Sodium	Pravastatin Sodium	Cipla USA Inc.	ANDA	Current
69097-185	Pravastatin Sodium	Pravastatin Sodium	Cipla USA Inc.	ANDA	Current
69097-186	Pravastatin Sodium	Pravastatin Sodium	Cipla USA Inc.	ANDA	Current