Application 204991

Type: ANDA
Sponsor: LUPIN 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	Approval date
A204991-001	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2019-03-06
A204991-002	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2019-03-06
A204991-003	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2019-03-06
A204991-004	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2019-03-06

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 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204991-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2019-03-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204991-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2019-03-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204991-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2019-03-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204991-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2019-03-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204991-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2019-03-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204991-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2019-03-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204991-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2019-03-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204991-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2019-03-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204991-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2019-03-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204991-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2019-03-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204991-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2019-03-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204991-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2019-03-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204991-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2019-03-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204991-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2019-03-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204991-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2019-03-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204991-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2019-03-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204991-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2019-03-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204991-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2019-03-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204991-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2019-03-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204991-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2019-03-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204991-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2019-03-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204991-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2019-03-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204991-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2019-03-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204991-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2019-03-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204991-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2019-03-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204991-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2019-03-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204991-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2019-03-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204991-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2019-03-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204991-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2019-03-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204991-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2019-03-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204991-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2019-03-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204991-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2019-03-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204991-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2019-03-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204991-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2019-03-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204991-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2019-03-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204991-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2019-03-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204991-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2019-03-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204991-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2019-03-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204991-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2019-03-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204991-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2019-03-06	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 112 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204991-001	BX	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204991-002	BX	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204991-003	BX	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204991-004	BX	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204991-001	BX	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204991-002	BX	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204991-003	BX	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204991-004	BX	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204991-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204991-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204991-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204991-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204991-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204991-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204991-003	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204991-004	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204991-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204991-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204991-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204991-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204991-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204991-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204991-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204991-004	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204991-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204991-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204991-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204991-004	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A204991-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204991-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204991-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204991-004	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204991-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204991-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204991-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204991-004	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204991-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204991-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204991-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204991-004	AB	1	`87673890dc5c…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	DIRECT RX	c3b70f79-45a3-0869-e053-2a95a90a3cdb	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204991 application number: ANDA204991 ndc (product): 72189-239
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	5868d3c2-ae17-4a7e-9580-7c3cf9bf009e	2024-04-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204991 application number: ANDA204991 ndc (product): 71335-1929
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Lupin Pharmaceuticals, Inc.	a5767370-15a2-45e5-b980-7af9523aea7b	2023-12-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204991 application number: ANDA204991 ndc (product): 68180-636 ndc (product): 68180-635 ndc (product): 68180-638 ndc (product): 68180-637
Atorvastatin Calcium	ATORVASTATIN CALCIUM	A-S Medication Solutions	85c38e0b-3d0b-4b04-990a-ed077a4c43e4	2023-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204991 application number: ANDA204991 ndc (product): 50090-5636
Atorvastatin Calcium	ATORVASTATIN CALCIUM	A-S Medication Solutions	d3f27113-785c-419e-955a-d6782fade438	2023-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204991 application number: ANDA204991 ndc (product): 50090-5634
Atorvastatin Calcium	ATORVASTATIN CALCIUM	A-S Medication Solutions	f4154300-65d4-4e31-97ad-b8d086c676e2	2023-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204991 application number: ANDA204991 ndc (product): 50090-5632

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
50090-5632	Atorvastatin Calcium	Atorvastatin Calcium	A-S Medication Solutions	ANDA	Current
50090-5634	Atorvastatin Calcium	Atorvastatin Calcium	A-S Medication Solutions	ANDA	Current
50090-5636	Atorvastatin Calcium	Atorvastatin Calcium	A-S Medication Solutions	ANDA	Current
50090-5639	Atorvastatin Calcium	Atorvastatin Calcium	A-S Medication Solutions	ANDA	Current
68071-2439	Atorvastatin Calcium	Atorvastatin Calcium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2452	Atorvastatin Calcium	Atorvastatin Calcium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2465	Atorvastatin Calcium	Atorvastatin Calcium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68180-635	Atorvastatin Calcium	Atorvastatin Calcium	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-635	Atorvastatin Calcium	Atorvastatin Calcium	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-635	Atorvastatin Calcium	Atorvastatin Calcium	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-635	Atorvastatin Calcium	Atorvastatin Calcium	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-635	Atorvastatin Calcium	Atorvastatin Calcium	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-635	Atorvastatin Calcium	Atorvastatin Calcium	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-636	Atorvastatin Calcium	Atorvastatin Calcium	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-636	Atorvastatin Calcium	Atorvastatin Calcium	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-636	Atorvastatin Calcium	Atorvastatin Calcium	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-636	Atorvastatin Calcium	Atorvastatin Calcium	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-636	Atorvastatin Calcium	Atorvastatin Calcium	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-636	Atorvastatin Calcium	Atorvastatin Calcium	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-637	Atorvastatin Calcium	Atorvastatin Calcium	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-637	Atorvastatin Calcium	Atorvastatin Calcium	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-637	Atorvastatin Calcium	Atorvastatin Calcium	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-637	Atorvastatin Calcium	Atorvastatin Calcium	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-637	Atorvastatin Calcium	Atorvastatin Calcium	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-637	Atorvastatin Calcium	Atorvastatin Calcium	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-638	Atorvastatin Calcium	Atorvastatin Calcium	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-638	Atorvastatin Calcium	Atorvastatin Calcium	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-638	Atorvastatin Calcium	Atorvastatin Calcium	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-638	Atorvastatin Calcium	Atorvastatin Calcium	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-638	Atorvastatin Calcium	Atorvastatin Calcium	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-638	Atorvastatin Calcium	Atorvastatin Calcium	Lupin Pharmaceuticals, Inc.	ANDA	Current
68788-7979	Atorvastatin Calcium	Atorvastatin Calcium	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7979	Atorvastatin Calcium	Atorvastatin Calcium	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-8132	Atorvastatin Calcium	Atorvastatin Calcium	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-3414	Atorvastatin Calcium	Atorvastatin Calcium	REMEDYREPACK INC.	ANDA	Current
71335-1929	Atorvastatin Calcium	Atorvastatin Calcium	Bryant Ranch Prepack	ANDA	Current
71335-1929	Atorvastatin Calcium	Atorvastatin Calcium	Bryant Ranch Prepack	ANDA	Current
72189-239	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	DIRECT RX	ANDA	Current
72189-239	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	DIRECT RX	ANDA	Current
72189-295	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	DirectRx	ANDA	Current