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 6 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	ee4f7a00-b330-47ed-8440-7317b43753cf	2023-08-31	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Proficient Rx LP	76bbea68-52d8-4ba9-a772-0ba75a38f2eb	2023-07-01	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	e24da1b9-e51d-489a-85f4-43227c210477	2023-06-15	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	5f392edb-f7fc-40b4-8446-35494e83a69e	2023-06-14	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	0514e340-54a7-470c-8072-c8113fddf2d9	2023-04-19	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Aphena Pharma Solutions - Tennessee, LLC	ab6c1601-5152-443c-98a0-876660d533e8	2023-03-20	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	ac89adcd-3226-4a66-8902-0f0a33be159a	2023-03-15	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	2aa6d21f-426a-42b0-aa96-4cc47f97f7ab	2023-02-06	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	3aa55393-11c9-4c31-8697-ecaad8c78857	2023-02-06	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	Proficient Rx LP	eaf91ddd-0d4f-4c77-9dba-a2a3abb86ea4	2022-11-01	Warnings, Adverse reactions	Name fallback brand name: ROSUVASTATIN CALCIUM generic name: ROSUVASTATIN CALCIUM
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	Proficient Rx LP	d1bd91fd-03fa-4e6c-80c1-ce58b158d8d6	2022-11-01	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	Proficient Rx LP	aa64d28f-0926-4ff2-bb28-578e5ef233eb	2022-11-01	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	Proficient Rx LP	a1b4d50b-eda3-437c-9c80-4d854361ddc2	2022-11-01	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	Proficient Rx LP	5a874865-3cbe-4589-9787-046feb9a2c46	2022-11-01	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin calcium generic name: ROSUVASTATIN CALCIUM
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

Reported adverse events (FAERS/openFDA)#

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