Application 209869

Type: ANDA
Sponsor: CHARTWELL RX

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
A209869-001	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2018-04-13
A209869-002	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2018-04-13
A209869-003	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2018-04-13
A209869-004	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2018-04-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209869-001	AB
A209869-002	AB
A209869-003	AB
A209869-004	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	A209869-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2018-04-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209869-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2018-04-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209869-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2018-04-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209869-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2018-04-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209869-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2018-04-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209869-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2018-04-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209869-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2018-04-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209869-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2018-04-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209869-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2018-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209869-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2018-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209869-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2018-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209869-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2018-04-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209869-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2018-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209869-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2018-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209869-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2018-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209869-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2018-04-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209869-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2018-04-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209869-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2018-04-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209869-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2018-04-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209869-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2018-04-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209869-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2018-04-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209869-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2018-04-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209869-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2018-04-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209869-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2018-04-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209869-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2018-04-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209869-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2018-04-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209869-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2018-04-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209869-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2018-04-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209869-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2018-04-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209869-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2018-04-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209869-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2018-04-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209869-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2018-04-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209869-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2018-04-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209869-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2018-04-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209869-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2018-04-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209869-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2018-04-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209869-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2018-04-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209869-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2018-04-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209869-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2018-04-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209869-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2018-04-13	`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	A209869-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209869-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209869-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209869-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209869-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209869-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209869-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209869-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209869-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209869-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209869-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209869-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209869-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209869-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209869-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209869-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209869-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209869-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209869-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209869-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209869-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209869-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209869-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209869-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209869-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209869-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209869-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209869-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209869-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209869-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209869-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209869-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209869-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209869-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209869-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209869-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209869-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209869-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209869-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209869-004	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 2 · 29 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	2290cad1-55c3-45a0-9d50-dd149678d191	2025-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869 ndc (product): 63629-8906
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	0bb2f1e8-9405-4f06-9a33-5ba06765a8e7	2025-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869 ndc (product): 63629-8909
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Aphena Pharma Solutions - Tennessee, LLC	308db0cc-0deb-99b6-e063-6394a90a9b74	2025-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Aphena Pharma Solutions - Tennessee, LLC	2e5c8a1c-b36f-d124-e063-6394a90a6fb5	2025-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	6bb60d07-0787-4d5f-8a8c-1224d5b02b2b	2024-08-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869 ndc (product): 63629-9162
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	06d85243-f9df-4984-b3d3-fcd8a7c554e9	2024-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869 ndc (product): 63629-9164
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	01beb7e2-ba01-4f2f-8554-4a8ec0941c9f	2024-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869 ndc (product): 63629-9165
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	73633a65-93b9-46dd-8f9f-d4b5c0089040	2024-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869 ndc (product): 63629-8904
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	70920620-37d6-4fe0-9d86-1fdffc2e6a99	2023-10-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869 ndc (product): 63629-8912

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 · 36 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55801-141	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	APPCO PHARMA LLC	ANDA	Current
55801-142	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	APPCO PHARMA LLC	ANDA	Current
55801-143	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	APPCO PHARMA LLC	ANDA	Current
55801-144	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	APPCO PHARMA LLC	ANDA	Current
63629-8904	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
63629-8904	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
63629-8905	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
63629-8905	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
63629-8906	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
63629-8906	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
63629-8909	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
63629-8909	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
63629-8910	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
63629-8910	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
63629-8911	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
63629-8911	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
63629-8912	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
63629-8912	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
63629-8913	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
63629-8913	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
63629-9162	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
63629-9162	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
63629-9163	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
63629-9163	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
63629-9164	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
63629-9164	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
63629-9165	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
63629-9165	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
70377-045	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	BIOCON PHARMA INC.,	ANDA	Current
70377-045	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	BIOCON PHARMA INC.,	ANDA	Current
70377-046	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	BIOCON PHARMA INC.,	ANDA	Current
70377-046	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	BIOCON PHARMA INC.,	ANDA	Current
70377-047	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	BIOCON PHARMA INC.,	ANDA	Current
70377-047	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	BIOCON PHARMA INC.,	ANDA	Current
70377-048	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	BIOCON PHARMA INC.,	ANDA	Current
70377-048	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	BIOCON PHARMA INC.,	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
53693	ORIG	2018-04-16