Application 213853

Type: ANDA
Sponsor: UMEDICA LABS PVT 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
A213853-001	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2020-08-19
A213853-002	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2020-08-19
A213853-003	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2020-08-19
A213853-004	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2020-08-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213853-001	AB
A213853-002	AB
A213853-003	AB
A213853-004	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 · 148 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	A213853-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	BX	2020-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213853-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	BX	2020-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213853-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	BX	2020-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213853-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	BX	2020-08-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213853-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	BX	2020-08-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213853-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	BX	2020-08-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213853-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	BX	2020-08-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213853-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	BX	2020-08-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213853-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	BX	2020-08-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213853-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	BX	2020-08-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213853-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	BX	2020-08-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213853-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	BX	2020-08-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213853-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	BX	2020-08-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213853-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	BX	2020-08-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213853-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	BX	2020-08-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213853-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	BX	2020-08-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213853-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	BX	2020-08-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213853-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	BX	2020-08-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213853-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	BX	2020-08-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213853-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	BX	2020-08-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213853-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	BX	2020-08-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213853-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	BX	2020-08-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213853-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	BX	2020-08-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213853-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	BX	2020-08-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213853-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	BX	2020-08-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213853-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	BX	2020-08-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213853-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	BX	2020-08-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213853-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	BX	2020-08-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213853-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	BX	2020-08-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213853-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	BX	2020-08-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213853-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	BX	2020-08-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213853-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	BX	2020-08-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213853-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	BX	2020-08-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213853-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	BX	2020-08-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213853-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	BX	2020-08-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213853-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	BX	2020-08-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213853-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	BX	2020-08-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213853-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	BX	2020-08-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213853-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	BX	2020-08-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213853-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	BX	2020-08-19	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 148 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	A213853-001	BX	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213853-002	BX	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213853-003	BX	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213853-004	BX	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213853-001	BX	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213853-002	BX	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213853-003	BX	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213853-004	BX	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213853-001	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213853-002	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213853-003	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213853-004	BX	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213853-001	BX	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213853-002	BX	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213853-003	BX	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213853-004	BX	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213853-001	BX	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213853-002	BX	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213853-003	BX	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213853-004	BX	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213853-001	BX	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213853-002	BX	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213853-003	BX	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213853-004	BX	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213853-001	BX	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213853-002	BX	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213853-003	BX	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213853-004	BX	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213853-001	BX	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213853-002	BX	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213853-003	BX	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213853-004	BX	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213853-001	BX	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213853-002	BX	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213853-003	BX	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213853-004	BX	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213853-001	BX	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213853-002	BX	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213853-003	BX	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213853-004	BX	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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atorvastatin calcium	ATORVASTATIN CALCIUM	REMEDYREPACK INC.	6600f22e-d303-4fe3-8212-accd6fb06e62	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213853 application number: ANDA213853
Atorvastatin calcium	ATORVASTATIN CALCIUM	REMEDYREPACK INC.	8821431a-c387-4b75-9540-f92bd455e961	2026-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213853 application number: ANDA213853
Atorvastatin calcium	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	20f820ba-9600-4b51-bf23-8c99e815674c	2026-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213853 application number: ANDA213853
Atorvastatin calcium	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	112ae40c-b612-405b-8f68-6d4bf09f9440	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213853 application number: ANDA213853
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Direct_Rx	0e24e7cb-1949-6686-e063-6394a90a4760	2026-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213853 application number: ANDA213853
Atorvastatin calcium	ATORVASTATIN CALCIUM	Umedica Laboratories USA Inc.	5a7594ca-30be-4350-827f-ef745a2a7e18	2026-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213853 application number: ANDA213853
Atorvastatin calcium	ATORVASTATIN CALCIUM	NIVAGEN PHARMACEUTICALS, INC.	7c58bf4a-4a92-4db8-89bc-4de1b5831efc	2025-12-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213853 application number: ANDA213853 ndc (product): 75834-256 ndc (product): 75834-257 ndc (product): 75834-258 ndc (product): 75834-255
Atorvastatin calcium	ATORVASTATIN CALCIUM	REMEDYREPACK INC.	604a011e-6c64-4895-8f6e-d28f119c4c22	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213853 application number: ANDA213853
Atorvastatin calcium	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	71cd9b85-4914-4b0b-97db-7aaf25983211	2025-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213853 application number: ANDA213853
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	DirectRX	d076309f-313a-1c71-e053-2995a90a7bb7	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213853 application number: ANDA213853 ndc (product): 72189-291
Atorvastatin calcium	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals,Inc.	f7e8c8d2-b74e-6afd-e053-6394a90af83e	2024-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213853 application number: ANDA213853
Atorvastatin calcium	ATORVASTATIN CALCIUM	Proficient Rx LP	acbbd2c4-60bd-4e01-ad7a-b9b3178569f0	2024-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213853 application number: ANDA213853

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68788-8298	Atorvastatin calcium	Atorvastatin calcium	Preferred Pharmaceuticals Inc.	ANDA	Current
72189-291	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	DirectRX	ANDA	Current
75834-255	Atorvastatin calcium	Atorvastatin calcium	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-255	Atorvastatin calcium	Atorvastatin calcium	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-255	Atorvastatin calcium	Atorvastatin calcium	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-255	Atorvastatin calcium	Atorvastatin calcium	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-255	Atorvastatin calcium	Atorvastatin calcium	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-255	Atorvastatin calcium	Atorvastatin calcium	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-256	Atorvastatin calcium	Atorvastatin calcium	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-256	Atorvastatin calcium	Atorvastatin calcium	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-256	Atorvastatin calcium	Atorvastatin calcium	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-256	Atorvastatin calcium	Atorvastatin calcium	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-256	Atorvastatin calcium	Atorvastatin calcium	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-256	Atorvastatin calcium	Atorvastatin calcium	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-257	Atorvastatin calcium	Atorvastatin calcium	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-257	Atorvastatin calcium	Atorvastatin calcium	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-257	Atorvastatin calcium	Atorvastatin calcium	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-257	Atorvastatin calcium	Atorvastatin calcium	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-257	Atorvastatin calcium	Atorvastatin calcium	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-257	Atorvastatin calcium	Atorvastatin calcium	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-258	Atorvastatin calcium	Atorvastatin calcium	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-258	Atorvastatin calcium	Atorvastatin calcium	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-258	Atorvastatin calcium	Atorvastatin calcium	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-258	Atorvastatin calcium	Atorvastatin calcium	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-258	Atorvastatin calcium	Atorvastatin calcium	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-258	Atorvastatin calcium	Atorvastatin calcium	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current