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 4 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	216d8a80-9bc6-493a-90d3-a00926b49572	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	7a969720-7994-43a1-97c0-5e7842ae2be4	2024-12-30	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Proficient Rx LP	dc7bfc79-9ee3-46e7-b55d-aba88648ad3b	2024-12-01	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Novadoz Pharmaceuticals LLC	d58f1f63-4bb6-413c-9730-ded3e8078618	2024-11-28	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	0ec87d67-4fe0-4f5a-aa6b-114042ebc249	2024-10-28	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	d147d4b2-5c2a-44d2-abb6-e77715f2b0f5	2024-10-28	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	8030f0bc-fb11-4c85-8058-ed6482689d1a	2024-10-28	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Bryant Ranch Prepack	1c97c9da-687b-47c1-9b9e-61f9a37bb9c4	2024-10-08	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	NCS HealthCare of KY, LLC dba Vangard Labs	d84f596d-8b99-419c-9a02-4b5e26aeaea8	2024-09-27	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Bryant Ranch Prepack	a9a5641f-9b7d-4a98-8dac-a3c53dde861f	2024-08-29	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
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

Reported adverse events (FAERS/openFDA)#

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