Application 208850

Type: ANDA
Sponsor: AMNEAL PHARMS CO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	TABLET;ORAL	5MG	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 43.

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
A208850-001	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2018-10-16
A208850-002	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2018-10-16
A208850-003	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2018-10-16
A208850-004	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2018-10-16

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.

Product history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A208850-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2018-10-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208850-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2018-10-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208850-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2018-10-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208850-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2018-10-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208850-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2018-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208850-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2018-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208850-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2018-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208850-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2018-10-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208850-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2018-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208850-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2018-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208850-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2018-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208850-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2018-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208850-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2018-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208850-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2018-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208850-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2018-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208850-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2018-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208850-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2018-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208850-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2018-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208850-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2018-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208850-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2018-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208850-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2018-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208850-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2018-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208850-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2018-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208850-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2018-10-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208850-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2018-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208850-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2018-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208850-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2018-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208850-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2018-10-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208850-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2018-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208850-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2018-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208850-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2018-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208850-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2018-10-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208850-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2018-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208850-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2018-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208850-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2018-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208850-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2018-10-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208850-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2018-10-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208850-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2018-10-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208850-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2018-10-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208850-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2018-10-16	`5bbf6a4d5a75…`

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 1 of 7 · 130 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	REMEDYREPACK INC.	cb942007-6ef1-4445-8dbd-6f4972148bf1	2026-09-09	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	TORRENT PHARMACEUTICALS LIMITED	6985e729-d963-4f32-89a1-727472b86daa	2026-09-02	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Rising Pharma Holdings, Inc.	5c992d3d-d754-48b6-a267-1451208352ed	2026-09-01	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	REMEDYREPACK INC.	c607da3c-47f5-4773-8391-2a7b0826d30e	2026-08-31	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	REMEDYREPACK INC.	f230f4fe-0dbd-4062-9e11-a3e74bcdcba8	2026-08-31	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Aurobindo Pharma Limited	47924917-bbd5-45de-96cb-c7ff9754da97	2026-08-28	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	REMEDYREPACK INC.	94245f53-2892-4209-8c94-c32c87d5b106	2026-08-27	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	2026-08-26	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	2026-08-26	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	2026-08-26	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	REMEDYREPACK INC.	d9b83920-26ae-462a-ac10-33fd1ed7738f	2026-08-14	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Bryant Ranch Prepack	23cc6801-f296-494e-b737-6d7c6df092c3	2026-08-11	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	Glenmark Pharmaceutials Inc., USA	392657a9-955c-42c2-814c-1890ece45afa	2026-08-07	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Redpharm Drug	57d1fb5b-1b85-7dd9-e063-6394a90a3fb1	2026-07-30	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Redpharm Drug	57d226e7-30f4-cecb-e063-6394a90a692f	2026-07-30	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	HEC Pharm USA Inc.	568a782b-1621-5e59-e063-6294a90a7fef	2026-07-28	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Zhejiang Yongtai Pharmaceutical Co., Ltd.	40c2900e-4659-49ce-ba4b-5df529b3c53b	2026-07-25	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	REMEDYREPACK INC.	11fad602-16c2-4c1f-bdf1-867d95f063ca	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Cadila Pharmaceuticals Limited	6802a946-a29c-4d41-997b-3c078ed8e74d	2026-07-02	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	NorthStar Rx, LLC	c622757d-7370-438b-8c2d-ef444a4f31dd	2026-06-19	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 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69238-1146	Rosuvastatin	Rosuvastatin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1146	Rosuvastatin	Rosuvastatin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1146	Rosuvastatin	Rosuvastatin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1146	Rosuvastatin	Rosuvastatin	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1146	Rosuvastatin	Rosuvastatin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1146	Rosuvastatin	Rosuvastatin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1147	Rosuvastatin	Rosuvastatin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1147	Rosuvastatin	Rosuvastatin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1147	Rosuvastatin	Rosuvastatin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1147	Rosuvastatin	Rosuvastatin	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1147	Rosuvastatin	Rosuvastatin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1147	Rosuvastatin	Rosuvastatin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1148	Rosuvastatin	Rosuvastatin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1148	Rosuvastatin	Rosuvastatin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1148	Rosuvastatin	Rosuvastatin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1148	Rosuvastatin	Rosuvastatin	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1148	Rosuvastatin	Rosuvastatin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1148	Rosuvastatin	Rosuvastatin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1149	Rosuvastatin	Rosuvastatin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1149	Rosuvastatin	Rosuvastatin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1149	Rosuvastatin	Rosuvastatin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1149	Rosuvastatin	Rosuvastatin	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1149	Rosuvastatin	Rosuvastatin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1149	Rosuvastatin	Rosuvastatin	Amneal Pharmaceuticals NY LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
54792	ORIG	2018-07-06