Application 203367

Type: ANDA
Sponsor: AUROBINDO PHARMA 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	TE codes	Approval date
A203367-001	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2017-02-02
A203367-002	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2017-02-02
A203367-003	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2017-02-02
A203367-004	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2017-02-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203367-001	AB
A203367-002	AB
A203367-003	AB
A203367-004	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	A203367-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2017-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203367-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2017-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203367-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2017-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203367-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2017-02-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203367-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2017-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203367-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2017-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203367-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2017-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203367-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2017-02-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203367-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2017-02-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203367-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2017-02-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203367-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2017-02-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203367-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2017-02-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203367-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2017-02-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203367-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2017-02-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203367-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2017-02-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203367-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2017-02-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203367-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2017-02-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203367-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2017-02-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203367-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2017-02-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203367-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2017-02-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203367-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2017-02-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203367-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2017-02-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203367-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2017-02-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203367-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2017-02-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203367-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2017-02-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203367-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2017-02-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203367-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2017-02-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203367-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2017-02-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203367-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2017-02-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203367-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2017-02-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203367-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2017-02-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203367-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2017-02-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203367-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2017-02-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203367-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2017-02-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203367-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2017-02-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203367-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2017-02-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203367-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2017-02-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203367-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2017-02-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203367-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2017-02-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203367-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2017-02-02	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 4 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-02-18 07:12 UTC	2024-02	A203367-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A203367-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A203367-003	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A203367-004	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203367-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A203367-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A203367-003	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A203367-004	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203367-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203367-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203367-003	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203367-004	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203367-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203367-002	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203367-003	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203367-004	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203367-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203367-002	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203367-003	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203367-004	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203367-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203367-002	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203367-003	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203367-004	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203367-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A203367-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A203367-003	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A203367-004	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203367-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A203367-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A203367-003	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A203367-004	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203367-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203367-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203367-003	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203367-004	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203367-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A203367-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A203367-003	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A203367-004	AB	1	`f41ea6bd6efb…`

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	Aurobindo Pharma Limited	b06ed801-ddee-4f56-924a-59fcb451eae6	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203367 application number: ANDA203367 ndc (product): 65862-634 ndc (product): 65862-635 ndc (product): 65862-632 ndc (product): 65862-633

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 · 40 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
57237-164	Pravastatin sodium	Pravastatin sodium	Rising Health, LLC	ANDA	Current
57237-164	Pravastatin sodium	Pravastatin sodium	Rising Health, LLC	ANDA	Current
57237-164	Pravastatin sodium	Pravastatin sodium	Rising Health, LLC	ANDA	Current
57237-164	Pravastatin sodium	Pravastatin sodium	Rising Health, LLC	ANDA	Current
57237-165	Pravastatin sodium	Pravastatin sodium	Rising Health, LLC	ANDA	Current
57237-165	Pravastatin sodium	Pravastatin sodium	Rising Health, LLC	ANDA	Current
57237-165	Pravastatin sodium	Pravastatin sodium	Rising Health, LLC	ANDA	Current
57237-165	Pravastatin sodium	Pravastatin sodium	Rising Health, LLC	ANDA	Current
57237-166	Pravastatin sodium	Pravastatin sodium	Rising Health, LLC	ANDA	Current
57237-166	Pravastatin sodium	Pravastatin sodium	Rising Health, LLC	ANDA	Current
57237-166	Pravastatin sodium	Pravastatin sodium	Rising Health, LLC	ANDA	Current
57237-166	Pravastatin sodium	Pravastatin sodium	Rising Health, LLC	ANDA	Current
57237-167	Pravastatin sodium	Pravastatin sodium	Rising Health, LLC	ANDA	Current
57237-167	Pravastatin sodium	Pravastatin sodium	Rising Health, LLC	ANDA	Current
57237-167	Pravastatin sodium	Pravastatin sodium	Rising Health, LLC	ANDA	Current
57237-167	Pravastatin sodium	Pravastatin sodium	Rising Health, LLC	ANDA	Current
65862-632	Pravastatin sodium	Pravastatin sodium	Aurobindo Pharma Limited	ANDA	Current
65862-632	Pravastatin sodium	Pravastatin sodium	Aurobindo Pharma Limited	ANDA	Current
65862-632	Pravastatin sodium	Pravastatin sodium	Aurobindo Pharma Limited	ANDA	Current
65862-632	Pravastatin sodium	Pravastatin sodium	Aurobindo Pharma Limited	ANDA	Current
65862-632	Pravastatin sodium	Pravastatin sodium	Aurobindo Pharma Limited	ANDA	Current
65862-633	Pravastatin sodium	Pravastatin sodium	Aurobindo Pharma Limited	ANDA	Current
65862-633	Pravastatin sodium	Pravastatin sodium	Aurobindo Pharma Limited	ANDA	Current
65862-633	Pravastatin sodium	Pravastatin sodium	Aurobindo Pharma Limited	ANDA	Current
65862-633	Pravastatin sodium	Pravastatin sodium	Aurobindo Pharma Limited	ANDA	Current
65862-633	Pravastatin sodium	Pravastatin sodium	Aurobindo Pharma Limited	ANDA	Current
65862-634	Pravastatin sodium	Pravastatin sodium	Aurobindo Pharma Limited	ANDA	Current
65862-634	Pravastatin sodium	Pravastatin sodium	Aurobindo Pharma Limited	ANDA	Current
65862-634	Pravastatin sodium	Pravastatin sodium	Aurobindo Pharma Limited	ANDA	Current
65862-634	Pravastatin sodium	Pravastatin sodium	Aurobindo Pharma Limited	ANDA	Current
65862-634	Pravastatin sodium	Pravastatin sodium	Aurobindo Pharma Limited	ANDA	Current
65862-635	Pravastatin sodium	Pravastatin sodium	Aurobindo Pharma Limited	ANDA	Current
65862-635	Pravastatin sodium	Pravastatin sodium	Aurobindo Pharma Limited	ANDA	Current
65862-635	Pravastatin sodium	Pravastatin sodium	Aurobindo Pharma Limited	ANDA	Current
65862-635	Pravastatin sodium	Pravastatin sodium	Aurobindo Pharma Limited	ANDA	Current
65862-635	Pravastatin sodium	Pravastatin sodium	Aurobindo Pharma Limited	ANDA	Current
68071-4894	Pravastatin sodium	Pravastatin sodium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4894	Pravastatin sodium	Pravastatin sodium	NuCare Pharmaceuticals,Inc.	ANDA	Current
70518-1731	Pravastatin sodium	Pravastatin sodium	REMEDYREPACK INC.	ANDA	Current
70518-1731	Pravastatin sodium	Pravastatin sodium	REMEDYREPACK INC.	ANDA	Current