Application 207653

Type: ANDA
Sponsor: INVENTIA HEALTHCARE PRIVATE LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	UNKNOWN	UNKNOWN	No	No
002	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	TABLET;ORAL	10MG	No	No
003	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	TABLET;ORAL	20MG	No	No
004	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	TABLET;ORAL	40MG	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
A207653-001	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2021-02-05
A207653-002	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2021-02-05
A207653-003	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2021-02-05
A207653-004	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2021-02-05

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 · 140 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	A207653-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2021-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207653-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2021-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207653-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2021-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207653-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2021-02-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207653-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2021-02-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207653-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2021-02-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207653-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2021-02-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207653-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2021-02-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207653-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2021-02-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207653-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2021-02-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207653-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2021-02-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207653-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2021-02-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207653-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2021-02-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207653-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2021-02-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207653-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2021-02-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207653-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2021-02-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207653-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2021-02-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207653-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2021-02-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207653-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2021-02-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207653-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2021-02-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207653-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2021-02-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207653-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2021-02-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207653-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2021-02-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207653-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2021-02-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207653-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2021-02-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207653-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2021-02-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207653-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2021-02-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207653-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2021-02-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207653-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2021-02-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207653-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2021-02-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207653-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2021-02-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207653-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2021-02-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207653-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2021-02-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207653-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2021-02-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207653-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2021-02-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207653-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2021-02-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207653-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2021-02-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207653-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2021-02-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207653-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2021-02-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207653-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2021-02-05	`d06236e962d9…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207653-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207653-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207653-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207653-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207653-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207653-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207653-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207653-004	AB	1	`5aa47cf7b7d7…`

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 5 of 7 · 132 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Bryant Ranch Prepack	199df185-dab0-4de1-95f7-a70e57b9c2b1	2024-08-29	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Bryant Ranch Prepack	c277c6fd-f8dd-41d8-8686-38c25d05d192	2024-08-29	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	Bryant Ranch Prepack	51d0ef20-c80d-44de-ac85-9b73608dba0b	2024-08-29	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	3b556f65-fae9-436f-9cc5-3160d1c9b18a	2024-08-23	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	aaadbf01-9cf4-4898-9a96-f0a20d55702b	2024-08-20	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	NuCare Pharmaceuticals, Inc.	20101145-4c4f-8f0a-e063-6394a90ae27d	2024-08-19	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	e5decd64-cde1-4d8d-9853-7243fb0e1722	2024-06-28	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	NuCare Pharmaceuticals,Inc.	9e694f6a-63a0-55e9-e053-2995a90a10fe	2024-06-20	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	NuCare Pharmaceuticals,Inc.	a2155aff-bf13-3f00-e053-2995a90a4d1d	2024-06-20	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	NuCare Pharmaceuticals,Inc.	1aca7a86-940b-c6e1-e063-6294a90a5944	2024-06-13	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	f07922e5-a963-4ecf-86db-c1ae12f85224	2024-06-10	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Bryant Ranch Prepack	d6645266-9626-430e-bf04-b6426525ae0a	2024-05-17	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Proficient Rx LP	3a03022c-ef11-4a68-829f-fae2d31969df	2024-03-01	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	Aphena Pharma Solutions - Tennessee, LLC	128d52ea-abad-c8ef-e063-6394a90a3fec	2024-02-29	Warnings, Adverse reactions	Name fallback brand name: ROSUVASTATIN CALCIUM generic name: ROSUVASTATIN CALCIUM
ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	Aphena Pharma Solutions - Tennessee, LLC	113160c7-7b41-5395-e063-6394a90a1e15	2024-02-19	Warnings, Adverse reactions	Name fallback brand name: ROSUVASTATIN CALCIUM generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	0ffb16d3-e14a-4d4e-9cbe-af9534ec1735	2024-01-07	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	7ec15f53-a7ec-4be5-9f26-d1078117b18b	2023-12-28	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	4a2abf58-ef55-46f4-a6bc-bc87bb88df78	2023-12-03	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	Bryant Ranch Prepack	eeb492b0-32d8-489e-ab60-6eec52a28efd	2023-11-21	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	Bryant Ranch Prepack	e41da8b8-db23-49e1-9ee0-55423d285980	2023-11-20	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin calcium generic name: ROSUVASTATIN CALCIUM

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49252-061	ROSUVASTATIN	rosuvastatin	Inventia Healthcare Limited	ANDA	Current
49252-061	ROSUVASTATIN	rosuvastatin	Inventia Healthcare Limited	ANDA	Current
49252-062	ROSUVASTATIN	rosuvastatin	Inventia Healthcare Limited	ANDA	Current
49252-062	ROSUVASTATIN	rosuvastatin	Inventia Healthcare Limited	ANDA	Current
49252-063	ROSUVASTATIN	rosuvastatin	Inventia Healthcare Limited	ANDA	Current
49252-063	ROSUVASTATIN	rosuvastatin	Inventia Healthcare Limited	ANDA	Current
49252-064	ROSUVASTATIN	rosuvastatin	Inventia Healthcare Limited	ANDA	Current
49252-064	ROSUVASTATIN	rosuvastatin	Inventia Healthcare Limited	ANDA	Current