Application 021992

Type: NDA
Sponsor: PF PRISM CV

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PRISTIQ	DESVENLAFAXINE SUCCINATE	TABLET, EXTENDED RELEASE;ORAL	EQ 50MG BASE	Yes	Yes
002	PRISTIQ	DESVENLAFAXINE SUCCINATE	TABLET, EXTENDED RELEASE;ORAL	EQ 100MG BASE	Yes	Yes
003	PRISTIQ	DESVENLAFAXINE SUCCINATE	TABLET, EXTENDED RELEASE;ORAL	EQ 25MG BASE	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021992-001	PRISTIQ	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-02-29
N021992-002	PRISTIQ	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-02-29
N021992-003	PRISTIQ	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-08-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N021992-001	AB
N021992-002	AB
N021992-003	AB

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N021992-001	8269040	2027-07-05	Drug substance
N021992-002	8269040	2027-07-05	Drug substance
N021992-003	8269040	2027-07-05	Drug substance	2015-02-02

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 · 123 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	N021992-001	PRISTIQ	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-02-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021992-002	PRISTIQ	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-02-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021992-003	PRISTIQ	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-08-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021992-001	PRISTIQ	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-02-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021992-002	PRISTIQ	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-02-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021992-003	PRISTIQ	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-08-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021992-001	PRISTIQ	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-02-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021992-002	PRISTIQ	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-02-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021992-003	PRISTIQ	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-08-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021992-001	PRISTIQ	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-02-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021992-002	PRISTIQ	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-02-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021992-003	PRISTIQ	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-08-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021992-001	PRISTIQ	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-02-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021992-002	PRISTIQ	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-02-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021992-003	PRISTIQ	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-08-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021992-001	PRISTIQ	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-02-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021992-002	PRISTIQ	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-02-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021992-003	PRISTIQ	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-08-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021992-001	PRISTIQ	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-02-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021992-002	PRISTIQ	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-02-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021992-003	PRISTIQ	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-08-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021992-001	PRISTIQ	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-02-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021992-002	PRISTIQ	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-02-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021992-003	PRISTIQ	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-08-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021992-001	PRISTIQ	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-02-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021992-002	PRISTIQ	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-02-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021992-003	PRISTIQ	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-08-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021992-001	PRISTIQ	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-02-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021992-002	PRISTIQ	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-02-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021992-003	PRISTIQ	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-08-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021992-001	PRISTIQ	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-02-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021992-002	PRISTIQ	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-02-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021992-003	PRISTIQ	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-08-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021992-001	PRISTIQ	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-02-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021992-002	PRISTIQ	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-02-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021992-003	PRISTIQ	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-08-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021992-001	PRISTIQ	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-02-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021992-002	PRISTIQ	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-02-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021992-003	PRISTIQ	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-08-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021992-001	PRISTIQ	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-02-29	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021992-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021992-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021992-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021992-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021992-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021992-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021992-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021992-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021992-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021992-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021992-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021992-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021992-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021992-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021992-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021992-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021992-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021992-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021992-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021992-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021992-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021992-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021992-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021992-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021992-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021992-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021992-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021992-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021992-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021992-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021992-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021992-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021992-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021992-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021992-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021992-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021992-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021992-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021992-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021992-001	AB	1	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 231 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	N021992-001	8269040	2027-07-05	Drug substance		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021992-002	8269040	2027-07-05	Drug substance		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021992-003	8269040	2027-07-05	Drug substance	2015-02-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021992-001	8269040	2027-07-05	Drug substance		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021992-002	8269040	2027-07-05	Drug substance		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021992-003	8269040	2027-07-05	Drug substance	2015-02-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021992-001	8269040	2027-07-05	Drug substance		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021992-002	8269040	2027-07-05	Drug substance		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021992-003	8269040	2027-07-05	Drug substance	2015-02-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021992-001	8269040	2027-07-05	Drug substance		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021992-002	8269040	2027-07-05	Drug substance		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021992-003	8269040	2027-07-05	Drug substance	2015-02-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021992-001	8269040	2027-07-05	Drug substance		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021992-002	8269040	2027-07-05	Drug substance		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021992-003	8269040	2027-07-05	Drug substance	2015-02-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021992-001	8269040	2027-07-05	Drug substance		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021992-002	8269040	2027-07-05	Drug substance		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021992-003	8269040	2027-07-05	Drug substance	2015-02-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021992-001	8269040	2027-07-05	Drug substance		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021992-002	8269040	2027-07-05	Drug substance		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021992-003	8269040	2027-07-05	Drug substance	2015-02-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021992-001	8269040	2027-07-05	Drug substance		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021992-002	8269040	2027-07-05	Drug substance		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021992-003	8269040	2027-07-05	Drug substance	2015-02-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021992-001	8269040	2027-07-05	Drug substance		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021992-002	8269040	2027-07-05	Drug substance		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021992-003	8269040	2027-07-05	Drug substance	2015-02-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021992-001	8269040	2027-07-05	Drug substance		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021992-002	8269040	2027-07-05	Drug substance		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021992-003	8269040	2027-07-05	Drug substance	2015-02-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021992-001	8269040	2027-07-05	Drug substance		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021992-002	8269040	2027-07-05	Drug substance		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021992-003	8269040	2027-07-05	Drug substance	2015-02-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021992-001	8269040	2027-07-05	Drug substance		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021992-002	8269040	2027-07-05	Drug substance		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021992-003	8269040	2027-07-05	Drug substance	2015-02-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021992-001	8269040	2027-07-05	Drug substance		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021992-002	8269040	2027-07-05	Drug substance		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021992-003	8269040	2027-07-05	Drug substance	2015-02-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021992-001	8269040	2027-07-05	Drug substance		`8072bd15b7f6…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021992-001	M-222	2021-02-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021992-002	M-222	2021-02-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021992-003	M-222	2021-02-06	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N021992-001	M-222	2021-02-06	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021992-002	M-222	2021-02-06	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021992-003	M-222	2021-02-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021992-001	M-222	2021-02-06	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021992-002	M-222	2021-02-06	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021992-003	M-222	2021-02-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021992-001	M-222	2021-02-06	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021992-002	M-222	2021-02-06	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021992-003	M-222	2021-02-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021992-001	M-222	2021-02-06	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021992-002	M-222	2021-02-06	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021992-003	M-222	2021-02-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021992-001	M-222	2021-02-06	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021992-002	M-222	2021-02-06	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021992-003	M-222	2021-02-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021992-001	M-222	2021-02-06	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021992-002	M-222	2021-02-06	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021992-003	M-222	2021-02-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021992-001	M-222	2021-02-06	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021992-002	M-222	2021-02-06	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021992-003	M-222	2021-02-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021992-001	M-222	2021-02-06	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021992-002	M-222	2021-02-06	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021992-003	M-222	2021-02-06	`ea99ee380514…`

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
Pristiq Extended-Release	DESVENLAFAXINE SUCCINATE	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	0f43610c-f290-46ea-d186-4f998ed99fce	2026-04-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021992 application number: NDA021992 ndc (product): 0008-1222 ndc (product): 0008-1210 ndc (product): 0008-1211

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 43 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0008-1210	Pristiq	desvenlafaxine succinate	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0008-1210	Pristiq	desvenlafaxine succinate	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0008-1210	Pristiq	desvenlafaxine succinate	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0008-1210	Pristiq	desvenlafaxine succinate	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0008-1210	Pristiq	desvenlafaxine succinate	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0008-1211	Pristiq	desvenlafaxine succinate	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0008-1211	Pristiq	desvenlafaxine succinate	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0008-1211	Pristiq	desvenlafaxine succinate	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0008-1211	Pristiq	desvenlafaxine succinate	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0008-1211	Pristiq	desvenlafaxine succinate	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0008-1222	Pristiq	desvenlafaxine succinate	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0008-1222	Pristiq	desvenlafaxine succinate	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0008-1222	Pristiq	desvenlafaxine succinate	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0008-1222	Pristiq	desvenlafaxine succinate	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0008-1222	Pristiq	desvenlafaxine succinate	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
35356-491	Pristiq	desvenlafaxine succinate	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	NDA	Current
43063-262	Pristiq	desvenlafaxine succinate	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-262	Pristiq	desvenlafaxine succinate	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-262	Pristiq	desvenlafaxine succinate	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-262	Pristiq	desvenlafaxine succinate	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-262	Pristiq	desvenlafaxine succinate	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-262	Pristiq	desvenlafaxine succinate	PD-Rx Pharmaceuticals, Inc.	NDA	Current
50090-4069	Desvenlafaxine Succinate	desvenlafaxine succinate	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
55154-4230	Pristiq	desvenlafaxine succinate	Cardinal Health	NDA	Current
55154-4235	Pristiq	desvenlafaxine succinate	Cardinal Health	NDA	Current
59762-1210	Desvenlafaxine Succinate	desvenlafaxine succinate	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-1210	Desvenlafaxine Succinate	desvenlafaxine succinate	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-1210	Desvenlafaxine Succinate	desvenlafaxine succinate	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-1210	Desvenlafaxine Succinate	desvenlafaxine succinate	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-1210	Desvenlafaxine Succinate	desvenlafaxine succinate	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-1210	Desvenlafaxine Succinate	desvenlafaxine succinate	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-1211	Desvenlafaxine Succinate	desvenlafaxine succinate	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-1211	Desvenlafaxine Succinate	desvenlafaxine succinate	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-1211	Desvenlafaxine Succinate	desvenlafaxine succinate	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-1211	Desvenlafaxine Succinate	desvenlafaxine succinate	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-1211	Desvenlafaxine Succinate	desvenlafaxine succinate	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-1211	Desvenlafaxine Succinate	desvenlafaxine succinate	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-1222	Desvenlafaxine Succinate	desvenlafaxine succinate	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-1222	Desvenlafaxine Succinate	desvenlafaxine succinate	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-1222	Desvenlafaxine Succinate	desvenlafaxine succinate	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-1222	Desvenlafaxine Succinate	desvenlafaxine succinate	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-1222	Desvenlafaxine Succinate	desvenlafaxine succinate	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-1222	Desvenlafaxine Succinate	desvenlafaxine succinate	Greenstone LLC	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75246	SUPPL	2023-08-22
75190	SUPPL	2023-08-21
69304	SUPPL	2021-11-12
69303	SUPPL	2021-11-12
69295	SUPPL	2021-11-12
68699	SUPPL	2021-09-21
68698	SUPPL	2021-09-21
68694	SUPPL	2021-09-21
52517	SUPPL	2018-02-08
52429	SUPPL	2018-02-06
50899	SUPPL	2017-12-27
50801	SUPPL	2017-12-21
50800	SUPPL	2017-12-21
46689	SUPPL	2017-01-06
45174	SUPPL	2016-08-26
45061	SUPPL	2016-08-26
38026	SUPPL	2014-11-17
29005	SUPPL	2014-11-14
38027	SUPPL	2014-07-29
6623	SUPPL	2014-07-21
38025	SUPPL	2013-12-24
29004	SUPPL	2013-12-24
6619	SUPPL	2013-12-13
38021	SUPPL	2013-12-11
6622	SUPPL	2013-03-15
38024	SUPPL	2013-02-20
38022	SUPPL	2013-02-20
6620	SUPPL	2013-02-19
6621	SUPPL	2012-12-11
38023	SUPPL	2012-12-10
29003	SUPPL	2012-03-12
38020	SUPPL	2012-03-09
6618	SUPPL	2011-04-13
16713	SUPPL	2011-04-11
16712	SUPPL	2011-03-07
6617	SUPPL	2011-03-07
29002	SUPPL	2011-02-03
16711	SUPPL	2011-01-31
6616	SUPPL	2011-01-25
16710	SUPPL	2011-01-10
29000	SUPPL	2010-10-20
16707	SUPPL	2010-10-18
16709	SUPPL	2010-09-10
6615	SUPPL	2010-09-09
29001	SUPPL	2010-07-14
16708	SUPPL	2010-07-12
6614	SUPPL	2010-02-22
38019	SUPPL	2010-02-17
28999	SUPPL	2010-01-25
6613	SUPPL	2010-01-25
28998	SUPPL	2009-11-24
28995	SUPPL	2009-11-24
6612	SUPPL	2009-11-24
38018	SUPPL	2009-11-17
16705	SUPPL	2009-11-05
38017	SUPPL	2009-09-18
16706	SUPPL	2009-09-18
28997	SUPPL	2009-04-29
38016	SUPPL	2009-04-28
38015	SUPPL	2009-02-04
28996	SUPPL	2009-02-03
42371	ORIG	2008-06-13
38014	ORIG	2008-03-05
6611	ORIG	2008-03-05
54152	SUPPL	1900-01-01
54151	SUPPL	1900-01-01
54150	SUPPL	1900-01-01
54149	SUPPL	1900-01-01