Application 206603

Type: ANDA
Sponsor: MANKIND PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	TABLET;ORAL	EQ 5MG BASE	No	No
002	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	TABLET;ORAL	EQ 10MG BASE	No	No
003	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	TABLET;ORAL	EQ 20MG BASE	No	No
004	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	TABLET;ORAL	EQ 40MG 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
A206603-001	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2025-05-16
A206603-002	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2025-05-16
A206603-003	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2025-05-16
A206603-004	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2025-05-16

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A206603-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL		2025-05-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A206603-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL		2025-05-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A206603-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL		2025-05-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A206603-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL		2025-05-16	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A206603-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL		2025-05-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206603-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL		2025-05-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206603-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL		2025-05-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206603-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL		2025-05-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206603-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL		2025-05-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206603-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL		2025-05-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206603-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL		2025-05-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206603-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL		2025-05-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206603-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL		2025-05-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206603-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL		2025-05-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206603-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL		2025-05-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206603-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL		2025-05-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206603-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL		2025-05-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206603-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL		2025-05-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206603-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL		2025-05-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206603-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL		2025-05-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206603-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2025-05-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206603-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2025-05-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206603-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2025-05-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206603-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2025-05-16	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206603-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL		2025-05-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206603-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL		2025-05-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206603-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL		2025-05-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206603-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL		2025-05-16	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A206603-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206603-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206603-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206603-004	AB	1	`6a471c1ec25d…`

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 · 122 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Bryant Ranch Prepack	8795a783-755d-426b-aa4f-1fc9965ba944	2023-11-20	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	Bryant Ranch Prepack	88ab1c85-e864-4879-8489-8365ded78bb5	2023-11-20	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Bryant Ranch Prepack	adcbfc8c-e4a7-4576-9f0a-42c59c6e2ad1	2023-11-20	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	6c061ef9-1dcd-4efd-b0ce-6f3ab91b1bc6	2023-09-17	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	9b8f614f-d49c-464b-b580-5fb9f2c25681	2023-09-14	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	7b2fc012-bf45-4a27-9e48-67926972918d	2023-09-10	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	2e998dc7-e2a5-41e4-8758-aff545bb1f14	2023-09-06	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	3a138e43-f123-47d1-b241-d3bcc7584e51	2023-09-06	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	8046d4fa-bd89-49f7-8204-9eb49b648748	2023-08-31	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	86fde296-d1c5-4fe8-9050-77c074914f63	2023-08-31	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.