Application 208647

Type: NDA
Sponsor: SUN PHARMA GLOBAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EZALLOR	ROSUVASTATIN CALCIUM	CAPSULE;ORAL	EQ 5MG BASE	Yes	No
002	EZALLOR	ROSUVASTATIN CALCIUM	CAPSULE;ORAL	EQ 10MG BASE	Yes	No
003	EZALLOR	ROSUVASTATIN CALCIUM	CAPSULE;ORAL	EQ 20MG BASE	Yes	No
004	EZALLOR	ROSUVASTATIN CALCIUM	CAPSULE;ORAL	EQ 40MG BASE	Yes	Yes

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	RLD / RS	Approval date
N208647-001	EZALLOR SPRINKLE	ROSUVASTATIN CALCIUM	EQ 5MG BASE	CAPSULE / ORAL	RLD	2018-12-18
N208647-002	EZALLOR SPRINKLE	ROSUVASTATIN CALCIUM	EQ 10MG BASE	CAPSULE / ORAL	RLD	2018-12-18
N208647-003	EZALLOR SPRINKLE	ROSUVASTATIN CALCIUM	EQ 20MG BASE	CAPSULE / ORAL	RLD	2018-12-18
N208647-004	EZALLOR SPRINKLE	ROSUVASTATIN CALCIUM	EQ 40MG BASE	CAPSULE / ORAL	RLD	2018-12-18

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N208647-001	10413543	2036-02-12	Drug product	2019-10-09
N208647-002	10413543	2036-02-12	Drug product	2019-10-09
N208647-003	10413543	2036-02-12	Drug product	2019-10-09
N208647-004	10413543	2036-02-12	Drug product	2019-10-09

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N208647-001	EZALLOR SPRINKLE	EQ 5MG BASE	CAPSULE / ORAL	RLD	2018-12-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208647-002	EZALLOR SPRINKLE	EQ 10MG BASE	CAPSULE / ORAL	RLD	2018-12-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208647-003	EZALLOR SPRINKLE	EQ 20MG BASE	CAPSULE / ORAL	RLD	2018-12-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208647-004	EZALLOR SPRINKLE	EQ 40MG BASE	CAPSULE / ORAL	RLD	2018-12-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208647-001	EZALLOR SPRINKLE	EQ 5MG BASE	CAPSULE / ORAL	RLD	2018-12-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208647-002	EZALLOR SPRINKLE	EQ 10MG BASE	CAPSULE / ORAL	RLD	2018-12-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208647-003	EZALLOR SPRINKLE	EQ 20MG BASE	CAPSULE / ORAL	RLD	2018-12-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208647-004	EZALLOR SPRINKLE	EQ 40MG BASE	CAPSULE / ORAL	RLD	2018-12-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208647-001	EZALLOR SPRINKLE	EQ 5MG BASE	CAPSULE / ORAL	RLD	2018-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208647-002	EZALLOR SPRINKLE	EQ 10MG BASE	CAPSULE / ORAL	RLD	2018-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208647-003	EZALLOR SPRINKLE	EQ 20MG BASE	CAPSULE / ORAL	RLD	2018-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208647-004	EZALLOR SPRINKLE	EQ 40MG BASE	CAPSULE / ORAL	RLD	2018-12-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208647-001	EZALLOR SPRINKLE	EQ 5MG BASE	CAPSULE / ORAL	RLD	2018-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208647-002	EZALLOR SPRINKLE	EQ 10MG BASE	CAPSULE / ORAL	RLD	2018-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208647-003	EZALLOR SPRINKLE	EQ 20MG BASE	CAPSULE / ORAL	RLD	2018-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208647-004	EZALLOR SPRINKLE	EQ 40MG BASE	CAPSULE / ORAL	RLD	2018-12-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208647-001	EZALLOR SPRINKLE	EQ 5MG BASE	CAPSULE / ORAL	RLD	2018-12-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208647-002	EZALLOR SPRINKLE	EQ 10MG BASE	CAPSULE / ORAL	RLD	2018-12-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208647-003	EZALLOR SPRINKLE	EQ 20MG BASE	CAPSULE / ORAL	RLD	2018-12-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208647-004	EZALLOR SPRINKLE	EQ 40MG BASE	CAPSULE / ORAL	RLD	2018-12-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208647-001	EZALLOR SPRINKLE	EQ 5MG BASE	CAPSULE / ORAL	RLD	2018-12-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208647-002	EZALLOR SPRINKLE	EQ 10MG BASE	CAPSULE / ORAL	RLD	2018-12-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208647-003	EZALLOR SPRINKLE	EQ 20MG BASE	CAPSULE / ORAL	RLD	2018-12-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208647-004	EZALLOR SPRINKLE	EQ 40MG BASE	CAPSULE / ORAL	RLD	2018-12-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208647-001	EZALLOR SPRINKLE	EQ 5MG BASE	CAPSULE / ORAL	RLD	2018-12-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208647-002	EZALLOR SPRINKLE	EQ 10MG BASE	CAPSULE / ORAL	RLD	2018-12-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208647-003	EZALLOR SPRINKLE	EQ 20MG BASE	CAPSULE / ORAL	RLD	2018-12-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208647-004	EZALLOR SPRINKLE	EQ 40MG BASE	CAPSULE / ORAL	RLD	2018-12-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208647-001	EZALLOR SPRINKLE	EQ 5MG BASE	CAPSULE / ORAL	RLD	2018-12-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208647-002	EZALLOR SPRINKLE	EQ 10MG BASE	CAPSULE / ORAL	RLD	2018-12-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208647-003	EZALLOR SPRINKLE	EQ 20MG BASE	CAPSULE / ORAL	RLD	2018-12-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208647-004	EZALLOR SPRINKLE	EQ 40MG BASE	CAPSULE / ORAL	RLD	2018-12-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208647-001	EZALLOR SPRINKLE	EQ 5MG BASE	CAPSULE / ORAL	RLD	2018-12-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208647-002	EZALLOR SPRINKLE	EQ 10MG BASE	CAPSULE / ORAL	RLD	2018-12-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208647-003	EZALLOR SPRINKLE	EQ 20MG BASE	CAPSULE / ORAL	RLD	2018-12-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208647-004	EZALLOR SPRINKLE	EQ 40MG BASE	CAPSULE / ORAL	RLD	2018-12-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208647-001	EZALLOR SPRINKLE	EQ 5MG BASE	CAPSULE / ORAL	RLD	2018-12-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208647-002	EZALLOR SPRINKLE	EQ 10MG BASE	CAPSULE / ORAL	RLD	2018-12-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208647-003	EZALLOR SPRINKLE	EQ 20MG BASE	CAPSULE / ORAL	RLD	2018-12-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208647-004	EZALLOR SPRINKLE	EQ 40MG BASE	CAPSULE / ORAL	RLD	2018-12-18	`5bbf6a4d5a75…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N208647-001	10413543	2036-02-12	Drug product	2019-10-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208647-002	10413543	2036-02-12	Drug product	2019-10-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208647-003	10413543	2036-02-12	Drug product	2019-10-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208647-004	10413543	2036-02-12	Drug product	2019-10-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208647-001	10413543	2036-02-12	Drug product	2019-10-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208647-002	10413543	2036-02-12	Drug product	2019-10-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208647-003	10413543	2036-02-12	Drug product	2019-10-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208647-004	10413543	2036-02-12	Drug product	2019-10-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208647-001	10413543	2036-02-12	Drug product	2019-10-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208647-002	10413543	2036-02-12	Drug product	2019-10-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208647-003	10413543	2036-02-12	Drug product	2019-10-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208647-004	10413543	2036-02-12	Drug product	2019-10-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208647-001	10413543	2036-02-12	Drug product	2019-10-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208647-002	10413543	2036-02-12	Drug product	2019-10-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208647-003	10413543	2036-02-12	Drug product	2019-10-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208647-004	10413543	2036-02-12	Drug product	2019-10-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208647-001	10413543	2036-02-12	Drug product	2019-10-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208647-002	10413543	2036-02-12	Drug product	2019-10-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208647-003	10413543	2036-02-12	Drug product	2019-10-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208647-004	10413543	2036-02-12	Drug product	2019-10-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208647-001	10413543	2036-02-12	Drug product	2019-10-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208647-002	10413543	2036-02-12	Drug product	2019-10-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208647-003	10413543	2036-02-12	Drug product	2019-10-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208647-004	10413543	2036-02-12	Drug product	2019-10-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208647-001	10413543	2036-02-12	Drug product	2019-10-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208647-002	10413543	2036-02-12	Drug product	2019-10-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208647-003	10413543	2036-02-12	Drug product	2019-10-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208647-004	10413543	2036-02-12	Drug product	2019-10-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208647-001	10413543	2036-02-12	Drug product	2019-10-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208647-002	10413543	2036-02-12	Drug product	2019-10-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208647-003	10413543	2036-02-12	Drug product	2019-10-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208647-004	10413543	2036-02-12	Drug product	2019-10-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208647-001	10413543	2036-02-12	Drug product	2019-10-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208647-002	10413543	2036-02-12	Drug product	2019-10-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208647-003	10413543	2036-02-12	Drug product	2019-10-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208647-004	10413543	2036-02-12	Drug product	2019-10-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208647-001	10413543	2036-02-12	Drug product	2019-10-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208647-002	10413543	2036-02-12	Drug product	2019-10-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208647-003	10413543	2036-02-12	Drug product	2019-10-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208647-004	10413543	2036-02-12	Drug product	2019-10-09	`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 6 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	Bryant Ranch Prepack	adcbfc8c-e4a7-4576-9f0a-42c59c6e2ad1	2023-11-20	Warnings, Adverse reactions	Name fallback 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 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 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 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 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 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 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 generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	ee4f7a00-b330-47ed-8440-7317b43753cf	2023-08-31	Warnings, Adverse reactions	Name fallback generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Proficient Rx LP	76bbea68-52d8-4ba9-a772-0ba75a38f2eb	2023-07-01	Warnings, Adverse reactions	Name fallback 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 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 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 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 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 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 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 generic name: ROSUVASTATIN CALCIUM
ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	Proficient Rx LP	eaf91ddd-0d4f-4c77-9dba-a2a3abb86ea4	2022-11-01	Warnings, Adverse reactions	Name fallback generic name: ROSUVASTATIN CALCIUM
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	Proficient Rx LP	d1bd91fd-03fa-4e6c-80c1-ce58b158d8d6	2022-11-01	Warnings, Adverse reactions	Name fallback generic name: ROSUVASTATIN CALCIUM
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	Proficient Rx LP	aa64d28f-0926-4ff2-bb28-578e5ef233eb	2022-11-01	Warnings, Adverse reactions	Name fallback 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 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
47335-984	EZALLOR SPRINKLE	ROSUVASTATIN	Sun Pharmaceutical Industries, Inc.	NDA	Current
47335-984	EZALLOR SPRINKLE	ROSUVASTATIN	Sun Pharmaceutical Industries, Inc.	NDA	Current
47335-984	EZALLOR SPRINKLE	ROSUVASTATIN	Sun Pharmaceutical Industries, Inc.	NDA	Current
47335-984	EZALLOR SPRINKLE	ROSUVASTATIN	Sun Pharmaceutical Industries, Inc.	NDA	Current
47335-985	EZALLOR SPRINKLE	ROSUVASTATIN	Sun Pharmaceutical Industries, Inc.	NDA	Current
47335-985	EZALLOR SPRINKLE	ROSUVASTATIN	Sun Pharmaceutical Industries, Inc.	NDA	Current
47335-985	EZALLOR SPRINKLE	ROSUVASTATIN	Sun Pharmaceutical Industries, Inc.	NDA	Current
47335-985	EZALLOR SPRINKLE	ROSUVASTATIN	Sun Pharmaceutical Industries, Inc.	NDA	Current
47335-986	EZALLOR SPRINKLE	ROSUVASTATIN	Sun Pharmaceutical Industries, Inc.	NDA	Current
47335-986	EZALLOR SPRINKLE	ROSUVASTATIN	Sun Pharmaceutical Industries, Inc.	NDA	Current
47335-986	EZALLOR SPRINKLE	ROSUVASTATIN	Sun Pharmaceutical Industries, Inc.	NDA	Current
47335-986	EZALLOR SPRINKLE	ROSUVASTATIN	Sun Pharmaceutical Industries, Inc.	NDA	Current
47335-987	EZALLOR SPRINKLE	ROSUVASTATIN	Sun Pharmaceutical Industries, Inc.	NDA	Current
47335-987	EZALLOR SPRINKLE	ROSUVASTATIN	Sun Pharmaceutical Industries, Inc.	NDA	Current
47335-987	EZALLOR SPRINKLE	ROSUVASTATIN	Sun Pharmaceutical Industries, Inc.	NDA	Current
47335-987	EZALLOR SPRINKLE	ROSUVASTATIN	Sun Pharmaceutical Industries, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81254	SUPPL	2025-02-14
81238	SUPPL	2025-02-13
77909	SUPPL	2024-03-21
77897	SUPPL	2024-03-21
75018	SUPPL	2023-08-07
75017	SUPPL	2023-08-07
75016	SUPPL	2023-08-07
75015	SUPPL	2023-08-07
75014	SUPPL	2023-08-07
75013	SUPPL	2023-08-07
75008	SUPPL	2023-08-07
75007	SUPPL	2023-08-07
75006	SUPPL	2023-08-07
75005	SUPPL	2023-08-07
75004	SUPPL	2023-08-07
75003	SUPPL	2023-08-07
64721	SUPPL	2020-09-29
64708	SUPPL	2020-09-28
62608	SUPPL	2020-04-20
62598	SUPPL	2020-04-20
59643	ORIG	2019-08-09
58192	SUPPL	2019-04-02
58135	SUPPL	2019-03-29
56935	ORIG	2018-12-21
56799	ORIG	2018-12-19