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 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
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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A209869-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2018-04-13	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209869-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2018-04-13	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209869-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2018-04-13	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209869-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2018-04-13	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A209869-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209869-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209869-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209869-004	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 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	ca7a4143-0091-4cd5-9061-cb05cc84ea4e	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869
Pravastatin sodium	PRAVASTATIN SODIUM	Bryant Ranch Prepack	f074240e-ef6b-45f2-8c4d-cb5c0dbc81f1	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869
Pravastatin sodium	PRAVASTATIN SODIUM	Bryant Ranch Prepack	3686a2df-51c4-4f1c-9d1e-d69207915144	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	d0641def-425e-4357-a6b6-24ce00424549	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869 ndc (product): 63629-9163
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	dcf46d0c-87da-4009-b238-eb5cf287c3ed	2026-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869 ndc (product): 63629-8911
Pravastatin sodium	PRAVASTATIN SODIUM	Golden State Medical Supply, Inc.	25b7276e-a69f-af63-e063-6394a90aecf2	2026-04-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869
Pravastatin sodium	PRAVASTATIN SODIUM	Biocon Pharma Inc.	9bd4a493-1f75-e33a-53fb-4e2fbc64a1eb	2026-02-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869 ndc (product): 70377-047 ndc (product): 70377-045 ndc (product): 70377-046 ndc (product): 70377-048
Pravastatin sodium	PRAVASTATIN SODIUM	A-S Medication Solutions	2f658680-939a-4212-8a5e-a44a896dd221	2026-02-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869
Pravastatin sodium	PRAVASTATIN SODIUM	A-S Medication Solutions	3b9fe7c9-791e-49a0-a005-ccf13036c365	2026-02-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869
Pravastatin sodium	PRAVASTATIN SODIUM	Northwind Health Company, LLC	40aa2d36-57ce-1f48-e063-6294a90affef	2026-01-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869
Pravastatin sodium	PRAVASTATIN SODIUM	Northwind Health Company, LLC	47207487-0c6d-8da3-e063-6294a90a8aee	2025-12-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869
Pravastatin sodium	PRAVASTATIN SODIUM	Bryant Ranch Prepack	4ed7a4d1-1183-4d95-8311-6d3e58feafa8	2025-11-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869
Pravastatin sodium	PRAVASTATIN SODIUM	Bryant Ranch Prepack	91c5b5c8-3379-4b84-aff7-ef6cfc65fe9f	2025-11-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869
Pravastatin sodium	PRAVASTATIN SODIUM	A-S Medication Solutions	33c141e9-76dc-4e32-9b2a-4621f32ac4bd	2025-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869
Pravastatin sodium	PRAVASTATIN SODIUM	A-S Medication Solutions	72693449-01ee-42b0-9902-566252324579	2025-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	7b7f5c28-78fa-4625-ad69-4291500e033d	2025-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	51800012-406b-4389-817f-88dd21e338d1	2025-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	a7f75948-2958-44c8-b52f-5e39e80cdd1f	2025-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	e358f314-9cbe-46a4-9564-6bedc7ef9d59	2025-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869 ndc (product): 63629-8910
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	80ddec55-6a18-4b87-8a07-6ae86ad62853	2025-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869 ndc (product): 63629-8913

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