Application 204168

Type: NDA
Sponsor: ALLERGAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FETZIMA	LEVOMILNACIPRAN HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	EQ 20MG BASE	Yes	No
002	FETZIMA	LEVOMILNACIPRAN HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	EQ 40MG BASE	Yes	No
003	FETZIMA	LEVOMILNACIPRAN HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	EQ 80MG BASE	Yes	No
004	FETZIMA	LEVOMILNACIPRAN HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	EQ 120MG 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	TE codes	RLD / RS	Approval date
N204168-001	FETZIMA	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-25
N204168-002	FETZIMA	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-25
N204168-003	FETZIMA	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 80MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-25
N204168-004	FETZIMA	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 120MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-07-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N204168-001	AB
N204168-002	AB
N204168-003	AB
N204168-004	AB

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N204168-001	RE43879	2026-01-11	U-839		2013-08-15
N204168-001	8481598	2031-03-02	U-839		2013-08-15
N204168-001	8865937	2032-05-23		Drug substance, Drug product	2014-11-20
N204168-002	RE43879	2026-01-11	U-839		2013-08-15
N204168-002	8481598	2031-03-02	U-839		2013-08-15
N204168-002	8865937	2032-05-23		Drug substance, Drug product	2014-11-20
N204168-003	RE43879	2026-01-11	U-839		2013-08-15
N204168-003	8481598	2031-03-02	U-839		2013-08-15
N204168-003	8865937	2032-05-23		Drug substance, Drug product	2014-11-20
N204168-004	RE43879	2026-01-11	U-839		2013-08-15
N204168-004	8481598	2031-03-02	U-839		2013-08-15
N204168-004	8865937	2032-05-23		Drug substance, Drug product	2014-11-20

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N204168-001	M-304	2026-03-24
N204168-002	M-304	2026-03-24
N204168-003	M-304	2026-03-24
N204168-004	M-304	2026-03-24

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 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N204168-001	FETZIMA	EQ 20MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204168-002	FETZIMA	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204168-003	FETZIMA	EQ 80MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204168-004	FETZIMA	EQ 120MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-07-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204168-001	FETZIMA	EQ 20MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204168-002	FETZIMA	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204168-003	FETZIMA	EQ 80MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204168-004	FETZIMA	EQ 120MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-07-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204168-001	FETZIMA	EQ 20MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2013-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204168-002	FETZIMA	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2013-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204168-003	FETZIMA	EQ 80MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2013-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204168-004	FETZIMA	EQ 120MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2013-07-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204168-001	FETZIMA	EQ 20MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2013-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204168-002	FETZIMA	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2013-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204168-003	FETZIMA	EQ 80MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2013-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204168-004	FETZIMA	EQ 120MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2013-07-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204168-001	FETZIMA	EQ 20MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2013-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204168-002	FETZIMA	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2013-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204168-003	FETZIMA	EQ 80MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2013-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204168-004	FETZIMA	EQ 120MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2013-07-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204168-001	FETZIMA	EQ 20MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2013-07-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204168-002	FETZIMA	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2013-07-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204168-003	FETZIMA	EQ 80MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2013-07-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204168-004	FETZIMA	EQ 120MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2013-07-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204168-001	FETZIMA	EQ 20MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2013-07-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204168-002	FETZIMA	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2013-07-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204168-003	FETZIMA	EQ 80MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2013-07-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204168-004	FETZIMA	EQ 120MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2013-07-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204168-001	FETZIMA	EQ 20MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2013-07-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204168-002	FETZIMA	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2013-07-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204168-003	FETZIMA	EQ 80MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2013-07-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204168-004	FETZIMA	EQ 120MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2013-07-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204168-001	FETZIMA	EQ 20MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2013-07-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204168-002	FETZIMA	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2013-07-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204168-003	FETZIMA	EQ 80MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2013-07-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204168-004	FETZIMA	EQ 120MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2013-07-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204168-001	FETZIMA	EQ 20MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2013-07-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204168-002	FETZIMA	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2013-07-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204168-003	FETZIMA	EQ 80MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2013-07-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204168-004	FETZIMA	EQ 120MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2013-07-25	`d06236e962d9…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N204168-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204168-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204168-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204168-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204168-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204168-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204168-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204168-004	AB	1	`31067a03dcf5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204168-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204168-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204168-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204168-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N204168-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N204168-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N204168-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N204168-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N204168-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N204168-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N204168-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N204168-004	AB	1	`8869cabd3fbd…`
2023-01-26 05:58 UTC	2023-01	N204168-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N204168-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N204168-003	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N204168-004	AB	1	`3bdfa0b2c4d7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N204168-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N204168-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N204168-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N204168-004	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 13 · 492 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N204168-001	RE43879	2026-01-11	U-839		2013-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204168-001	8481598	2031-03-02	U-839		2013-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204168-001	8865937	2032-05-23		Drug substance, Drug product	2014-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204168-002	RE43879	2026-01-11	U-839		2013-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204168-002	8481598	2031-03-02	U-839		2013-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204168-002	8865937	2032-05-23		Drug substance, Drug product	2014-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204168-003	RE43879	2026-01-11	U-839		2013-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204168-003	8481598	2031-03-02	U-839		2013-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204168-003	8865937	2032-05-23		Drug substance, Drug product	2014-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204168-004	RE43879	2026-01-11	U-839		2013-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204168-004	8481598	2031-03-02	U-839		2013-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204168-004	8865937	2032-05-23		Drug substance, Drug product	2014-11-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204168-001	RE43879	2026-01-11	U-839		2013-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204168-001	8481598	2031-03-02	U-839		2013-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204168-001	8865937	2032-05-23		Drug substance, Drug product	2014-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204168-002	RE43879	2026-01-11	U-839		2013-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204168-002	8481598	2031-03-02	U-839		2013-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204168-002	8865937	2032-05-23		Drug substance, Drug product	2014-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204168-003	RE43879	2026-01-11	U-839		2013-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204168-003	8481598	2031-03-02	U-839		2013-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204168-003	8865937	2032-05-23		Drug substance, Drug product	2014-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204168-004	RE43879	2026-01-11	U-839		2013-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204168-004	8481598	2031-03-02	U-839		2013-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204168-004	8865937	2032-05-23		Drug substance, Drug product	2014-11-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204168-001	RE43879	2026-01-11	U-839		2013-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204168-001	8481598	2031-03-02	U-839		2013-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204168-001	8865937	2032-05-23		Drug substance, Drug product	2014-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204168-002	RE43879	2026-01-11	U-839		2013-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204168-002	8481598	2031-03-02	U-839		2013-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204168-002	8865937	2032-05-23		Drug substance, Drug product	2014-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204168-003	RE43879	2026-01-11	U-839		2013-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204168-003	8481598	2031-03-02	U-839		2013-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204168-003	8865937	2032-05-23		Drug substance, Drug product	2014-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204168-004	RE43879	2026-01-11	U-839		2013-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204168-004	8481598	2031-03-02	U-839		2013-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204168-004	8865937	2032-05-23		Drug substance, Drug product	2014-11-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204168-001	RE43879	2026-01-11	U-839		2013-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204168-001	8481598	2031-03-02	U-839		2013-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204168-001	8865937	2032-05-23		Drug substance, Drug product	2014-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204168-002	RE43879	2026-01-11	U-839		2013-08-15	`fd3edfee7708…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N204168-001	M-304	2026-03-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204168-002	M-304	2026-03-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204168-003	M-304	2026-03-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204168-004	M-304	2026-03-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204168-001	M-304	2026-03-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204168-002	M-304	2026-03-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204168-003	M-304	2026-03-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204168-004	M-304	2026-03-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204168-001	M-304	2026-03-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204168-002	M-304	2026-03-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204168-003	M-304	2026-03-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204168-004	M-304	2026-03-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204168-001	M-304	2026-03-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204168-002	M-304	2026-03-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204168-003	M-304	2026-03-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204168-004	M-304	2026-03-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204168-001	M-304	2026-03-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204168-002	M-304	2026-03-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204168-003	M-304	2026-03-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204168-004	M-304	2026-03-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204168-001	M-304	2026-03-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204168-002	M-304	2026-03-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204168-003	M-304	2026-03-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204168-004	M-304	2026-03-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204168-001	M-304	2026-03-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204168-002	M-304	2026-03-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204168-003	M-304	2026-03-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204168-004	M-304	2026-03-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204168-001	M-304	2026-03-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204168-002	M-304	2026-03-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204168-003	M-304	2026-03-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204168-004	M-304	2026-03-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204168-001	M-304	2026-03-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204168-002	M-304	2026-03-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204168-003	M-304	2026-03-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204168-004	M-304	2026-03-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204168-001	M-304	2026-03-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204168-002	M-304	2026-03-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204168-003	M-304	2026-03-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204168-004	M-304	2026-03-24	`d06236e962d9…`

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
Fetzima	LEVOMILNACIPRAN HYDROCHLORIDE	Allergan, Inc.	f371258d-91b3-4b6a-ac99-434a1964c3af	2024-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 204168 application number: NDA204168 ndc (product): 0456-2240 ndc (product): 0456-2212 ndc (product): 0456-2220 ndc (product): 0456-2202 ndc (product): 0456-2280

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 35 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0456-2202	Fetzima	LEVOMILNACIPRAN HYDROCHLORIDE	Allergan, Inc.	NDA	Current
0456-2202	Fetzima	LEVOMILNACIPRAN HYDROCHLORIDE	Allergan, Inc.	NDA	Current
0456-2202	Fetzima	LEVOMILNACIPRAN HYDROCHLORIDE	Allergan, Inc.	NDA	Current
0456-2202	Fetzima	LEVOMILNACIPRAN HYDROCHLORIDE	Allergan, Inc.	NDA	Current
0456-2202	Fetzima	LEVOMILNACIPRAN HYDROCHLORIDE	Allergan, Inc.	NDA	Current
0456-2202	Fetzima	LEVOMILNACIPRAN HYDROCHLORIDE	Allergan USA, Inc.	NDA	Current
0456-2202	Fetzima	LEVOMILNACIPRAN HYDROCHLORIDE	Allergan, Inc.	NDA	Current
0456-2212	Fetzima	LEVOMILNACIPRAN HYDROCHLORIDE	Allergan, Inc.	NDA	Current
0456-2212	Fetzima	LEVOMILNACIPRAN HYDROCHLORIDE	Allergan, Inc.	NDA	Current
0456-2212	Fetzima	LEVOMILNACIPRAN HYDROCHLORIDE	Allergan, Inc.	NDA	Current
0456-2212	Fetzima	LEVOMILNACIPRAN HYDROCHLORIDE	Allergan, Inc.	NDA	Current
0456-2212	Fetzima	LEVOMILNACIPRAN HYDROCHLORIDE	Allergan, Inc.	NDA	Current
0456-2212	Fetzima	LEVOMILNACIPRAN HYDROCHLORIDE	Allergan USA, Inc.	NDA	Current
0456-2212	Fetzima	LEVOMILNACIPRAN HYDROCHLORIDE	Allergan, Inc.	NDA	Current
0456-2220	Fetzima	LEVOMILNACIPRAN HYDROCHLORIDE	Allergan, Inc.	NDA	Current
0456-2220	Fetzima	LEVOMILNACIPRAN HYDROCHLORIDE	Allergan, Inc.	NDA	Current
0456-2220	Fetzima	LEVOMILNACIPRAN HYDROCHLORIDE	Allergan, Inc.	NDA	Current
0456-2220	Fetzima	LEVOMILNACIPRAN HYDROCHLORIDE	Allergan, Inc.	NDA	Current
0456-2220	Fetzima	LEVOMILNACIPRAN HYDROCHLORIDE	Allergan, Inc.	NDA	Current
0456-2220	Fetzima	LEVOMILNACIPRAN HYDROCHLORIDE	Allergan USA, Inc.	NDA	Current
0456-2220	Fetzima	LEVOMILNACIPRAN HYDROCHLORIDE	Allergan, Inc.	NDA	Current
0456-2240	Fetzima	LEVOMILNACIPRAN HYDROCHLORIDE	Allergan, Inc.	NDA	Current
0456-2240	Fetzima	LEVOMILNACIPRAN HYDROCHLORIDE	Allergan, Inc.	NDA	Current
0456-2240	Fetzima	LEVOMILNACIPRAN HYDROCHLORIDE	Allergan, Inc.	NDA	Current
0456-2240	Fetzima	LEVOMILNACIPRAN HYDROCHLORIDE	Allergan, Inc.	NDA	Current
0456-2240	Fetzima	LEVOMILNACIPRAN HYDROCHLORIDE	Allergan, Inc.	NDA	Current
0456-2240	Fetzima	LEVOMILNACIPRAN HYDROCHLORIDE	Allergan USA, Inc.	NDA	Current
0456-2240	Fetzima	LEVOMILNACIPRAN HYDROCHLORIDE	Allergan, Inc.	NDA	Current
0456-2280	Fetzima	LEVOMILNACIPRAN HYDROCHLORIDE	Allergan, Inc.	NDA	Current
0456-2280	Fetzima	LEVOMILNACIPRAN HYDROCHLORIDE	Allergan, Inc.	NDA	Current
0456-2280	Fetzima	LEVOMILNACIPRAN HYDROCHLORIDE	Allergan, Inc.	NDA	Current
0456-2280	Fetzima	LEVOMILNACIPRAN HYDROCHLORIDE	Allergan, Inc.	NDA	Current
0456-2280	Fetzima	LEVOMILNACIPRAN HYDROCHLORIDE	Allergan, Inc.	NDA	Current
0456-2280	Fetzima	LEVOMILNACIPRAN HYDROCHLORIDE	Allergan USA, Inc.	NDA	Current
0456-2280	Fetzima	LEVOMILNACIPRAN HYDROCHLORIDE	Allergan, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78266	SUPPL	2024-04-25
78228	SUPPL	2024-04-24
78201	SUPPL	2024-04-22
75242	SUPPL	2023-08-22
75172	SUPPL	2023-08-21
73891	SUPPL	2023-03-28
73870	SUPPL	2023-03-27
68770	SUPPL	2021-09-24
68769	SUPPL	2021-09-24
68725	SUPPL	2021-09-22
61055	SUPPL	2019-11-26
61048	SUPPL	2019-11-26
60304	SUPPL	2019-10-08
50895	SUPPL	2017-12-27
50807	SUPPL	2017-12-21
46743	SUPPL	2017-01-10
46690	SUPPL	2017-01-06
40362	SUPPL	2014-08-05
40363	SUPPL	2014-07-23
10304	SUPPL	2014-07-23
32523	SUPPL	2014-05-27
24461	ORIG	2014-03-14
22946	ORIG	2014-03-14
19533	ORIG	2013-07-30
10303	ORIG	2013-07-29