Application 205945

Type: ANDA
Sponsor: MICRO LABS LTD INDIA

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
A205945-001	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-11-07
A205945-002	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-11-07
A205945-003	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-11-07
A205945-004	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2019-11-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205945-001	AB
A205945-002	AB
A205945-003	AB
A205945-004	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 · 156 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	A205945-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-11-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205945-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-11-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205945-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-11-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205945-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2019-11-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205945-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-11-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205945-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-11-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205945-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-11-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205945-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2019-11-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205945-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-11-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205945-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-11-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205945-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-11-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205945-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2019-11-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205945-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-11-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205945-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-11-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205945-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-11-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205945-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2019-11-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205945-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-11-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205945-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-11-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205945-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-11-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205945-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2019-11-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205945-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-11-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205945-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-11-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205945-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-11-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205945-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2019-11-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205945-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-11-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205945-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-11-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205945-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-11-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205945-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2019-11-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205945-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-11-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205945-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-11-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205945-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-11-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205945-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2019-11-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205945-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-11-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205945-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-11-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205945-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-11-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205945-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2019-11-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205945-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-11-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205945-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-11-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205945-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-11-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205945-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2019-11-07	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 156 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	A205945-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205945-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205945-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205945-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205945-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205945-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205945-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205945-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205945-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205945-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205945-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205945-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205945-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205945-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205945-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205945-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205945-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205945-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205945-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205945-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205945-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205945-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205945-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205945-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205945-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205945-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205945-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205945-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205945-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205945-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205945-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205945-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205945-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205945-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205945-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205945-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205945-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205945-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205945-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205945-004	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Micro Labs Limited	2e94161c-3360-4fb0-bb3a-048fdc1d137a	2025-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205945 application number: ANDA205945 ndc (product): 42571-174 ndc (product): 42571-172 ndc (product): 42571-175 ndc (product): 42571-173
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Coupler LLC	2d93e3c4-59cc-cff4-e063-6394a90a8f7f	2025-02-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205945 application number: ANDA205945

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
42571-172	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Micro Labs Limited	ANDA	Current
42571-172	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Micro Labs Limited	ANDA	Current
42571-172	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Micro Labs Limited	ANDA	Current
42571-172	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Micro Labs Limited	ANDA	Current
42571-172	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Micro Labs Limited	ANDA	Current
42571-172	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Micro Labs Limited	ANDA	Current
42571-172	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Micro Labs Limited	ANDA	Current
42571-173	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Micro Labs Limited	ANDA	Current
42571-173	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Micro Labs Limited	ANDA	Current
42571-173	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Micro Labs Limited	ANDA	Current
42571-173	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Micro Labs Limited	ANDA	Current
42571-173	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Micro Labs Limited	ANDA	Current
42571-173	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Micro Labs Limited	ANDA	Current
42571-173	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Micro Labs Limited	ANDA	Current
42571-174	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Micro Labs Limited	ANDA	Current
42571-174	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Micro Labs Limited	ANDA	Current
42571-174	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Micro Labs Limited	ANDA	Current
42571-174	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Micro Labs Limited	ANDA	Current
42571-174	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Micro Labs Limited	ANDA	Current
42571-174	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Micro Labs Limited	ANDA	Current
42571-174	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Micro Labs Limited	ANDA	Current
42571-175	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Micro Labs Limited	ANDA	Current
42571-175	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Micro Labs Limited	ANDA	Current
42571-175	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Micro Labs Limited	ANDA	Current
42571-175	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Micro Labs Limited	ANDA	Current
42571-175	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Micro Labs Limited	ANDA	Current
42571-175	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Micro Labs Limited	ANDA	Current
42571-175	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Micro Labs Limited	ANDA	Current
50090-4880	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	A-S Medication Solutions	ANDA	Current
50090-4880	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	A-S Medication Solutions	ANDA	Current
50090-4964	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	A-S Medication Solutions	ANDA	Current
50090-4964	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	A-S Medication Solutions	ANDA	Current
50090-4972	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	A-S Medication Solutions	ANDA	Current
50090-5051	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	A-S Medication Solutions	ANDA	Current
50090-5051	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	A-S Medication Solutions	ANDA	Current
50090-5162	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	A-S Medication Solutions	ANDA	Current
68071-2293	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2293	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals,Inc.	ANDA	Current
70518-2843	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	REMEDYREPACK INC.	ANDA	Current
70518-2843	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	REMEDYREPACK INC.	ANDA	Current