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 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
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 2 of 4 · 152 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	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…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207653-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2021-02-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207653-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2021-02-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207653-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2021-02-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207653-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2021-02-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207653-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2021-02-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207653-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2021-02-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207653-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2021-02-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207653-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2021-02-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207653-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2021-02-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207653-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2021-02-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207653-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2021-02-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207653-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2021-02-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207653-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2021-02-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207653-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2021-02-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207653-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2021-02-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207653-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2021-02-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207653-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2021-02-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207653-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2021-02-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207653-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2021-02-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207653-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2021-02-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207653-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2021-02-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207653-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2021-02-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207653-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2021-02-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207653-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2021-02-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207653-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2021-02-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207653-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2021-02-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207653-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2021-02-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207653-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2021-02-05	`4b0b4de00fa7…`

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 7 of 7 · 128 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Proficient Rx LP	a9478b12-89d2-42a4-a310-707a87ef43d7	2022-08-01	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Proficient Rx LP	3066f572-e3db-4bf8-b9ee-bd32d9ed8c13	2022-06-01	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Proficient Rx LP	dcc22d05-cff6-42f9-b9fa-930f2084753f	2022-05-01	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Proficient Rx LP	c40d5c38-3585-47ed-ad81-6ad2da91c9c8	2022-04-01	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	Aphena Pharma Solutions - Tennessee, LLC	a5ee9510-e691-49ec-a5cd-49e70371ee4d	2019-01-09	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	Aphena Pharma Solutions - Tennessee, LLC	410a0a03-6751-4c3d-82bf-c7c6a4081fdd	2018-11-13	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	Aphena Pharma Solutions - Tennessee, LLC	cbef0681-705c-48fd-add9-1042658ef85d	2018-09-12	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	Aphena Pharma Solutions - Tennessee, LLC	69dfa637-2a81-4c7e-8fef-d4b4ab4c3f25	2018-06-30	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin calcium generic name: ROSUVASTATIN CALCIUM

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 · 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