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 3 of 7 · 131 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Westminster Pharmaceuticals, LLC	02797697-300a-43db-92cf-9b78f08626be	2025-11-26	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Preferred Pharmaceuticals Inc.	1eb971e3-de67-46ae-a8ef-8a7d2805cfdd	2025-10-28	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	NuCare Pharmaceuticals, Inc.	3493b809-74b0-71b0-e063-6294a90a9a99	2025-10-07	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	American Health Packaging	b7491a1a-570e-40ea-b65b-f956c9e284a6	2025-10-01	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	REMEDYREPACK INC.	f230f4fe-0dbd-4062-9e11-a3e74bcdcba8	2025-09-30	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	REMEDYREPACK INC.	c607da3c-47f5-4773-8391-2a7b0826d30e	2025-09-29	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	Preferred Pharmaceuticals Inc.,	e432e043-c019-4d58-94ca-7c1d85f5cd40	2025-09-18	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Preferred Pharmaceuticals Inc.	b94b5b36-c04e-45ee-b933-59c4302f2661	2025-09-18	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Preferred Pharmaceuticals, Inc.	6ef51f7c-2899-4b09-bf8b-09e5b4ac3424	2025-09-18	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Preferred Pharmaceuticals Inc.	31b3894a-1139-4f07-ac29-dda53844dc4b	2025-09-17	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	NorthStar RxLLC	17d71c80-fade-4735-acec-60738d26dd01	2025-08-11	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	Proficient Rx LP	45033c5f-4246-491a-8707-10f840ff2b6c	2025-08-01	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	Biocon Pharma Inc	033d8c8f-bbe9-96b5-fd53-cb0ef929857a	2025-05-30	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Bryant Ranch Prepack	4bd37cda-9928-456c-86be-aaccccf2e450	2025-05-15	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Bryant Ranch Prepack	ebb0c5d6-d816-44fa-8422-82aa63076d55	2025-04-28	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Golden State Medical Supply, Inc.	7c3af5aa-2223-463a-e053-2a91aa0a16f9	2025-04-02	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Cranbury Pharmaceuticals, LLC	606d16fb-82e4-420d-9456-09997562b528	2025-03-27	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	85ed9283-4e16-41bf-95ed-01b62640fd2c	2025-02-19	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Quallent Pharmaceuticals Health LLC	6f978191-775e-4745-9c07-99e5be888afe	2025-02-07	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Bryant Ranch Prepack	3dd06868-6b71-4ddd-bc9c-57e1cf6656a5	2025-01-24	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