Application 214659

Type: ANDA
Sponsor: DR REDDYS LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	TABLET;ORAL	EQ 10MG BASE	No	No
002	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	TABLET;ORAL	EQ 20MG BASE	No	No
003	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	TABLET;ORAL	EQ 40MG BASE	No	No
004	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	TABLET;ORAL	EQ 80MG BASE	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
A214659-001	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2021-07-14
A214659-002	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2021-07-14
A214659-003	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2021-07-14
A214659-004	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2021-07-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214659-001	AB
A214659-002	AB
A214659-003	AB
A214659-004	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 4 · 132 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	A214659-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2021-07-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214659-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2021-07-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214659-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2021-07-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214659-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2021-07-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214659-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2021-07-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214659-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2021-07-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214659-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2021-07-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214659-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2021-07-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214659-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2021-07-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214659-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2021-07-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214659-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2021-07-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214659-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2021-07-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214659-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2021-07-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214659-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2021-07-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214659-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2021-07-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214659-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2021-07-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214659-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2021-07-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214659-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2021-07-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214659-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2021-07-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214659-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2021-07-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214659-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2021-07-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214659-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2021-07-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214659-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2021-07-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214659-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2021-07-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214659-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2021-07-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214659-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2021-07-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214659-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2021-07-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214659-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2021-07-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214659-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2021-07-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214659-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2021-07-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214659-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2021-07-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214659-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2021-07-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214659-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2021-07-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214659-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2021-07-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214659-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2021-07-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214659-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2021-07-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214659-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2021-07-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214659-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2021-07-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214659-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2021-07-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214659-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2021-07-14	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 108 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	A214659-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214659-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214659-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214659-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214659-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214659-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214659-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214659-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214659-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214659-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214659-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214659-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214659-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214659-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214659-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214659-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214659-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214659-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214659-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214659-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214659-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214659-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214659-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214659-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214659-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214659-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214659-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214659-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214659-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214659-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214659-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214659-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214659-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214659-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214659-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214659-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214659-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214659-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214659-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214659-004	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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Dr. Reddy's Laboratories Inc	aaf960d1-8bf9-64c6-1e70-8aa33b0ce549	2026-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214659 application number: ANDA214659
Atorvastatin Calcium	ATORVASTATIN CALCIUM	REMEDYREPACK INC.	632ddd78-9e76-4230-944d-dff85d945238	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214659 application number: ANDA214659
Atorvastatin Calcium	ATORVASTATIN CALCIUM	REMEDYREPACK INC.	a519e355-84f0-40d1-b586-e6e8eadb5b0f	2026-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214659 application number: ANDA214659
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Coupler LLC	2d916667-7b3e-ea20-e063-6294a90a52da	2025-02-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214659 application number: ANDA214659
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Coupler LLC	2c658654-87ee-b52a-e063-6294a90a11d6	2025-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214659 application number: ANDA214659
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	a20bac35-a3d7-4e97-95c2-2502107d61c2	2024-11-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214659 application number: ANDA214659
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	9c435528-4c44-44c6-bb10-049a72533c2f	2024-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214659 application number: ANDA214659
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	a33838d7-4e5e-4079-9d3d-00c2048cf776	2024-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214659 application number: ANDA214659
Atorvastatin Calcium	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals,Inc.	fa2d8d38-dbd0-43fd-e053-6294a90a4e94	2024-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214659 application number: ANDA214659
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Dr. Reddy's Laboratories Inc	652f77a0-2145-896d-c760-e99e87507161	2024-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214659 application number: ANDA214659 ndc (product): 43598-830 ndc (product): 43598-833 ndc (product): 43598-831 ndc (product): 43598-832

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
43598-830	Atorvastatin Calcium	Atorvastatin Calcium	Dr. Reddy's Laboratories Inc	ANDA	Current
43598-831	Atorvastatin Calcium	Atorvastatin Calcium	Dr. Reddy's Laboratories Inc	ANDA	Current
43598-832	Atorvastatin Calcium	Atorvastatin Calcium	Dr. Reddy's Laboratories Inc	ANDA	Current
43598-833	Atorvastatin Calcium	Atorvastatin Calcium	Dr. Reddy's Laboratories Inc	ANDA	Current