Application 216848

Type: ANDA
Sponsor: LEPU PHARM

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 44.

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
A216848-001	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2022-11-03
A216848-002	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2022-11-03
A216848-003	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2022-11-03
A216848-004	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2022-11-03

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 2 of 3 · 112 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216848-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2022-11-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216848-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2022-11-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216848-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2022-11-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216848-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2022-11-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216848-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2022-11-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216848-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2022-11-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216848-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2022-11-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216848-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2022-11-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216848-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2022-11-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216848-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2022-11-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216848-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2022-11-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216848-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2022-11-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216848-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2022-11-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216848-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2022-11-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216848-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2022-11-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216848-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2022-11-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216848-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2022-11-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216848-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2022-11-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216848-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2022-11-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216848-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2022-11-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216848-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2022-11-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216848-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2022-11-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216848-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2022-11-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216848-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2022-11-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216848-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2022-11-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216848-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2022-11-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216848-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2022-11-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216848-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2022-11-03	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216848-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2022-11-03	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216848-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2022-11-03	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216848-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2022-11-03	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216848-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2022-11-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216848-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2022-11-03	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A216848-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2022-11-03	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A216848-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2022-11-03	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A216848-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2022-11-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216848-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2022-11-03	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A216848-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2022-11-03	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A216848-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2022-11-03	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A216848-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2022-11-03	`ea1830bbd6c7…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-05-13 08:27 UTC	2023-05	A216848-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A216848-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A216848-003	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A216848-004	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A216848-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A216848-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A216848-003	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A216848-004	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A216848-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A216848-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A216848-003	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A216848-004	AB	1	`3a93d1ddd44b…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
atorvastatin calcium	ATORVASTATIN CALCIUM	Lepu Pharmaceutical Technology Co., Ltd.	173474b6-26b4-46f2-a12a-64753ae5e905	2025-10-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216848 application number: ANDA216848 ndc (product): 82137-016 ndc (product): 82137-017 ndc (product): 82137-019 ndc (product): 82137-018

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
82137-016	atorvastatin calcium	atorvastatin calcium	Lepu Pharmaceutical Technology Co., Ltd.	ANDA	Current
82137-017	atorvastatin calcium	atorvastatin calcium	Lepu Pharmaceutical Technology Co., Ltd.	ANDA	Current
82137-018	atorvastatin calcium	atorvastatin calcium	Lepu Pharmaceutical Technology Co., Ltd.	ANDA	Current
82137-019	atorvastatin calcium	atorvastatin calcium	Lepu Pharmaceutical Technology Co., Ltd.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84046	ORIG	2025-11-04