Application 212516

Type: NDA
Sponsor: SUN PHARMA GLOBAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DRIZALMA SPRINKLE	DULOXETINE HYDROCHLORIDE	CAPSULE, DELAYED RELEASE;ORAL	EQ 20MG BASE	Yes	No
002	DRIZALMA SPRINKLE	DULOXETINE HYDROCHLORIDE	CAPSULE, DELAYED RELEASE;ORAL	EQ 30MG BASE	Yes	No
003	DRIZALMA SPRINKLE	DULOXETINE HYDROCHLORIDE	CAPSULE, DELAYED RELEASE;ORAL	EQ 40MG BASE	Yes	No
004	DRIZALMA SPRINKLE	DULOXETINE HYDROCHLORIDE	CAPSULE, DELAYED RELEASE;ORAL	EQ 60MG BASE	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N212516-001	DRIZALMA SPRINKLE	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19
N212516-002	DRIZALMA SPRINKLE	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19
N212516-003	DRIZALMA SPRINKLE	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19
N212516-004	DRIZALMA SPRINKLE	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2019-07-19

Orange Book patents#

Current patent rows page 1 of 1 · 20 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N212516-001	10413525	2037-04-13	Drug product	2019-10-07
N212516-001	10959982	2037-04-13	Drug product	2021-04-19
N212516-001	11202772	2037-04-13	Drug product	2022-02-01
N212516-001	12171742	2037-04-13	Drug product	2025-01-10
N212516-001	9839626	2037-04-13	Drug product	2019-08-02
N212516-002	10413525	2037-04-13	Drug product	2019-10-07
N212516-002	10959982	2037-04-13	Drug product	2021-04-19
N212516-002	11202772	2037-04-13	Drug product	2022-02-01
N212516-002	12171742	2037-04-13	Drug product	2025-01-10
N212516-002	9839626	2037-04-13	Drug product	2019-08-02
N212516-003	10413525	2037-04-13	Drug product	2019-10-07
N212516-003	10959982	2037-04-13	Drug product	2021-04-19
N212516-003	11202772	2037-04-13	Drug product	2022-02-01
N212516-003	12171742	2037-04-13	Drug product	2025-01-10
N212516-003	9839626	2037-04-13	Drug product	2019-08-02
N212516-004	10413525	2037-04-13	Drug product	2019-10-07
N212516-004	10959982	2037-04-13	Drug product	2021-04-19
N212516-004	11202772	2037-04-13	Drug product	2022-02-01
N212516-004	12171742	2037-04-13	Drug product	2025-01-10
N212516-004	9839626	2037-04-13	Drug product	2019-08-02

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 4 · 160 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N212516-001	DRIZALMA SPRINKLE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212516-002	DRIZALMA SPRINKLE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212516-003	DRIZALMA SPRINKLE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212516-004	DRIZALMA SPRINKLE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2019-07-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212516-001	DRIZALMA SPRINKLE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212516-002	DRIZALMA SPRINKLE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212516-003	DRIZALMA SPRINKLE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212516-004	DRIZALMA SPRINKLE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2019-07-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212516-001	DRIZALMA SPRINKLE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212516-002	DRIZALMA SPRINKLE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212516-003	DRIZALMA SPRINKLE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212516-004	DRIZALMA SPRINKLE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2019-07-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212516-001	DRIZALMA SPRINKLE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212516-002	DRIZALMA SPRINKLE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212516-003	DRIZALMA SPRINKLE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212516-004	DRIZALMA SPRINKLE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2019-07-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212516-001	DRIZALMA SPRINKLE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212516-002	DRIZALMA SPRINKLE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212516-003	DRIZALMA SPRINKLE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212516-004	DRIZALMA SPRINKLE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2019-07-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212516-001	DRIZALMA SPRINKLE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212516-002	DRIZALMA SPRINKLE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212516-003	DRIZALMA SPRINKLE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212516-004	DRIZALMA SPRINKLE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2019-07-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212516-001	DRIZALMA SPRINKLE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212516-002	DRIZALMA SPRINKLE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212516-003	DRIZALMA SPRINKLE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212516-004	DRIZALMA SPRINKLE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2019-07-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212516-001	DRIZALMA SPRINKLE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212516-002	DRIZALMA SPRINKLE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212516-003	DRIZALMA SPRINKLE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212516-004	DRIZALMA SPRINKLE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2019-07-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212516-001	DRIZALMA SPRINKLE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212516-002	DRIZALMA SPRINKLE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212516-003	DRIZALMA SPRINKLE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212516-004	DRIZALMA SPRINKLE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2019-07-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212516-001	DRIZALMA SPRINKLE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212516-002	DRIZALMA SPRINKLE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212516-003	DRIZALMA SPRINKLE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212516-004	DRIZALMA SPRINKLE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2019-07-19	`d06236e962d9…`

Observed Orange Book patent history#

Patent history page 1 of 15 · 600 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N212516-001	10413525	2037-04-13	Drug product	2019-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212516-001	10959982	2037-04-13	Drug product	2021-04-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212516-001	11202772	2037-04-13	Drug product	2022-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212516-001	12171742	2037-04-13	Drug product	2025-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212516-001	9839626	2037-04-13	Drug product	2019-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212516-002	10413525	2037-04-13	Drug product	2019-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212516-002	10959982	2037-04-13	Drug product	2021-04-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212516-002	11202772	2037-04-13	Drug product	2022-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212516-002	12171742	2037-04-13	Drug product	2025-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212516-002	9839626	2037-04-13	Drug product	2019-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212516-003	10413525	2037-04-13	Drug product	2019-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212516-003	10959982	2037-04-13	Drug product	2021-04-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212516-003	11202772	2037-04-13	Drug product	2022-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212516-003	12171742	2037-04-13	Drug product	2025-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212516-003	9839626	2037-04-13	Drug product	2019-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212516-004	10413525	2037-04-13	Drug product	2019-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212516-004	10959982	2037-04-13	Drug product	2021-04-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212516-004	11202772	2037-04-13	Drug product	2022-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212516-004	12171742	2037-04-13	Drug product	2025-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212516-004	9839626	2037-04-13	Drug product	2019-08-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212516-001	10413525	2037-04-13	Drug product	2019-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212516-001	10959982	2037-04-13	Drug product	2021-04-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212516-001	11202772	2037-04-13	Drug product	2022-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212516-001	12171742	2037-04-13	Drug product	2025-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212516-001	9839626	2037-04-13	Drug product	2019-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212516-002	10413525	2037-04-13	Drug product	2019-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212516-002	10959982	2037-04-13	Drug product	2021-04-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212516-002	11202772	2037-04-13	Drug product	2022-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212516-002	12171742	2037-04-13	Drug product	2025-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212516-002	9839626	2037-04-13	Drug product	2019-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212516-003	10413525	2037-04-13	Drug product	2019-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212516-003	10959982	2037-04-13	Drug product	2021-04-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212516-003	11202772	2037-04-13	Drug product	2022-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212516-003	12171742	2037-04-13	Drug product	2025-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212516-003	9839626	2037-04-13	Drug product	2019-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212516-004	10413525	2037-04-13	Drug product	2019-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212516-004	10959982	2037-04-13	Drug product	2021-04-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212516-004	11202772	2037-04-13	Drug product	2022-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212516-004	12171742	2037-04-13	Drug product	2025-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212516-004	9839626	2037-04-13	Drug product	2019-08-02	`31067a03dcf5…`

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DRIZALMA SPRINKLE	DULOXETINE	SUN PHARMACEUTICAL INDUSTRIES, INC.	b41423b8-dfec-4d79-ba3c-e43a87803d85	2024-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 212516 application number: NDA212516 ndc (product): 47335-617 ndc (product): 47335-618 ndc (product): 47335-616 ndc (product): 47335-619

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
47335-616	DRIZALMA SPRINKLE	Duloxetine	SUN PHARMACEUTICAL INDUSTRIES, INC.	NDA	Current
47335-616	DRIZALMA SPRINKLE	Duloxetine	SUN PHARMACEUTICAL INDUSTRIES, INC.	NDA	Current
47335-616	DRIZALMA SPRINKLE	Duloxetine	SUN PHARMACEUTICAL INDUSTRIES, INC.	NDA	Current
47335-616	DRIZALMA SPRINKLE	Duloxetine	SUN PHARMACEUTICAL INDUSTRIES, INC.	NDA	Current
47335-616	Duloxetine	Duloxetine	SUN PHARMACEUTICAL INDUSTRIES, INC.	NDA	Current
47335-617	DRIZALMA SPRINKLE	Duloxetine	SUN PHARMACEUTICAL INDUSTRIES, INC.	NDA	Current
47335-617	DRIZALMA SPRINKLE	Duloxetine	SUN PHARMACEUTICAL INDUSTRIES, INC.	NDA	Current
47335-617	DRIZALMA SPRINKLE	Duloxetine	SUN PHARMACEUTICAL INDUSTRIES, INC.	NDA	Current
47335-617	DRIZALMA SPRINKLE	Duloxetine	SUN PHARMACEUTICAL INDUSTRIES, INC.	NDA	Current
47335-617	Duloxetine	Duloxetine	SUN PHARMACEUTICAL INDUSTRIES, INC.	NDA	Current
47335-618	DRIZALMA SPRINKLE	Duloxetine	SUN PHARMACEUTICAL INDUSTRIES, INC.	NDA	Current
47335-618	DRIZALMA SPRINKLE	Duloxetine	SUN PHARMACEUTICAL INDUSTRIES, INC.	NDA	Current
47335-618	DRIZALMA SPRINKLE	Duloxetine	SUN PHARMACEUTICAL INDUSTRIES, INC.	NDA	Current
47335-618	DRIZALMA SPRINKLE	Duloxetine	SUN PHARMACEUTICAL INDUSTRIES, INC.	NDA	Current
47335-618	Duloxetine	Duloxetine	SUN PHARMACEUTICAL INDUSTRIES, INC.	NDA	Current
47335-619	DRIZALMA SPRINKLE	Duloxetine	SUN PHARMACEUTICAL INDUSTRIES, INC.	NDA	Current
47335-619	DRIZALMA SPRINKLE	Duloxetine	SUN PHARMACEUTICAL INDUSTRIES, INC.	NDA	Current
47335-619	DRIZALMA SPRINKLE	Duloxetine	SUN PHARMACEUTICAL INDUSTRIES, INC.	NDA	Current
47335-619	DRIZALMA SPRINKLE	Duloxetine	SUN PHARMACEUTICAL INDUSTRIES, INC.	NDA	Current
47335-619	Duloxetine	Duloxetine	SUN PHARMACEUTICAL INDUSTRIES, INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75262	SUPPL	2023-08-22
75156	SUPPL	2023-08-21
75155	SUPPL	2023-08-21
68200	SUPPL	2021-07-27
68181	SUPPL	2021-07-26
68180	SUPPL	2021-07-26
63704	SUPPL	2020-06-25
63694	SUPPL	2020-06-25
63693	SUPPL	2020-06-25
61735	ORIG	2020-01-29
59434	ORIG	2019-07-24
59395	ORIG	2019-07-22
59389	ORIG	2019-07-22
62971	ORIG	1900-01-01