Application 209501

Type: NDA
Sponsor: PF PRISM CV

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LYRICA CR	PREGABALIN	TABLET, EXTENDED RELEASE;ORAL	82.5MG	Yes	No
002	LYRICA CR	PREGABALIN	TABLET, EXTENDED RELEASE;ORAL	165MG	Yes	No
003	LYRICA CR	PREGABALIN	TABLET, EXTENDED RELEASE;ORAL	330MG	Yes	Yes

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
N209501-001	LYRICA CR	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11
N209501-002	LYRICA CR	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11
N209501-003	LYRICA CR	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2017-10-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N209501-001	AB
N209501-002	AB
N209501-003	AB

Orange Book patents#

Current patent rows page 1 of 1 · 24 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209501-001	10022447	2026-11-02	U-2136		2018-08-16
N209501-001	10022447	2026-11-02	U-2137		2018-08-16
N209501-001	8945620	2026-11-02	U-2136	Drug product	2017-11-09
N209501-001	8945620	2026-11-02	U-2137	Drug product	2017-11-09
N209501-001	9144559	2026-11-02		Drug product	2017-11-09
N209501-001	10022447*PED	2027-05-02		Pediatric extension
N209501-001	8945620*PED	2027-05-02		Pediatric extension
N209501-001	9144559*PED	2027-05-02		Pediatric extension
N209501-002	10022447	2026-11-02	U-2136		2018-08-16
N209501-002	10022447	2026-11-02	U-2137		2018-08-16
N209501-002	8945620	2026-11-02	U-2136	Drug product	2017-11-09
N209501-002	8945620	2026-11-02	U-2137	Drug product	2017-11-09
N209501-002	9144559	2026-11-02		Drug product	2017-11-09
N209501-002	10022447*PED	2027-05-02		Pediatric extension
N209501-002	8945620*PED	2027-05-02		Pediatric extension
N209501-002	9144559*PED	2027-05-02		Pediatric extension
N209501-003	10022447	2026-11-02	U-2136		2018-08-16
N209501-003	10022447	2026-11-02	U-2137		2018-08-16
N209501-003	8945620	2026-11-02	U-2136	Drug product	2017-11-09
N209501-003	8945620	2026-11-02	U-2137	Drug product	2017-11-09
N209501-003	9144559	2026-11-02		Drug product	2017-11-09
N209501-003	10022447*PED	2027-05-02		Pediatric extension
N209501-003	8945620*PED	2027-05-02		Pediatric extension
N209501-003	9144559*PED	2027-05-02		Pediatric extension

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	N209501-001	LYRICA CR	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209501-002	LYRICA CR	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209501-003	LYRICA CR	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2017-10-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209501-001	LYRICA CR	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209501-002	LYRICA CR	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209501-003	LYRICA CR	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2017-10-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209501-001	LYRICA CR	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209501-002	LYRICA CR	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209501-003	LYRICA CR	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2017-10-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209501-001	LYRICA CR	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209501-002	LYRICA CR	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209501-003	LYRICA CR	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2017-10-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209501-001	LYRICA CR	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209501-002	LYRICA CR	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209501-003	LYRICA CR	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2017-10-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209501-001	LYRICA CR	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209501-002	LYRICA CR	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209501-003	LYRICA CR	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2017-10-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209501-001	LYRICA CR	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209501-002	LYRICA CR	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209501-003	LYRICA CR	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2017-10-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209501-001	LYRICA CR	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209501-002	LYRICA CR	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209501-003	LYRICA CR	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2017-10-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209501-001	LYRICA CR	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209501-002	LYRICA CR	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209501-003	LYRICA CR	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2017-10-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209501-001	LYRICA CR	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209501-002	LYRICA CR	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209501-003	LYRICA CR	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2017-10-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209501-001	LYRICA CR	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209501-002	LYRICA CR	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209501-003	LYRICA CR	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2017-10-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209501-001	LYRICA CR	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209501-002	LYRICA CR	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209501-003	LYRICA CR	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2017-10-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209501-001	LYRICA CR	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209501-002	LYRICA CR	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209501-003	LYRICA CR	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2017-10-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209501-001	LYRICA CR	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 99 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	N209501-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209501-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209501-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209501-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209501-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209501-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209501-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209501-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209501-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209501-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209501-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209501-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209501-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209501-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209501-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209501-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209501-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209501-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209501-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209501-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209501-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209501-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209501-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209501-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209501-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209501-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209501-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209501-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209501-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209501-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209501-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209501-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209501-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209501-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209501-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209501-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209501-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209501-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209501-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209501-001	AB	1	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 26 · 1,008 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	N209501-001	10022447	2026-11-02	U-2137		2018-08-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209501-001	10022447	2026-11-02	U-2136		2018-08-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209501-001	8945620	2026-11-02	U-2136	Drug product	2017-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209501-001	8945620	2026-11-02	U-2137	Drug product	2017-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209501-001	9144559	2026-11-02		Drug product	2017-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209501-001	10022447*PED	2027-05-02		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209501-001	8945620*PED	2027-05-02		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209501-001	9144559*PED	2027-05-02		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209501-002	10022447	2026-11-02	U-2137		2018-08-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209501-002	10022447	2026-11-02	U-2136		2018-08-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209501-002	8945620	2026-11-02	U-2137	Drug product	2017-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209501-002	8945620	2026-11-02	U-2136	Drug product	2017-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209501-002	9144559	2026-11-02		Drug product	2017-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209501-002	10022447*PED	2027-05-02		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209501-002	8945620*PED	2027-05-02		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209501-002	9144559*PED	2027-05-02		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209501-003	10022447	2026-11-02	U-2137		2018-08-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209501-003	10022447	2026-11-02	U-2136		2018-08-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209501-003	8945620	2026-11-02	U-2137	Drug product	2017-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209501-003	8945620	2026-11-02	U-2136	Drug product	2017-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209501-003	9144559	2026-11-02		Drug product	2017-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209501-003	10022447*PED	2027-05-02		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209501-003	8945620*PED	2027-05-02		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209501-003	9144559*PED	2027-05-02		Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209501-001	10022447	2026-11-02	U-2137		2018-08-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209501-001	10022447	2026-11-02	U-2136		2018-08-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209501-001	8945620	2026-11-02	U-2136	Drug product	2017-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209501-001	8945620	2026-11-02	U-2137	Drug product	2017-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209501-001	9144559	2026-11-02		Drug product	2017-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209501-001	10022447*PED	2027-05-02		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209501-001	8945620*PED	2027-05-02		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209501-001	9144559*PED	2027-05-02		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209501-002	10022447	2026-11-02	U-2137		2018-08-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209501-002	10022447	2026-11-02	U-2136		2018-08-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209501-002	8945620	2026-11-02	U-2137	Drug product	2017-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209501-002	8945620	2026-11-02	U-2136	Drug product	2017-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209501-002	9144559	2026-11-02		Drug product	2017-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209501-002	10022447*PED	2027-05-02		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209501-002	8945620*PED	2027-05-02		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209501-002	9144559*PED	2027-05-02		Pediatric extension		`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 45 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N209501-001	NP	2020-10-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209501-001	PED	2021-04-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209501-002	NP	2020-10-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209501-002	PED	2021-04-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209501-003	NP	2020-10-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209501-003	PED	2021-04-11	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N209501-001	PED	2021-04-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209501-002	PED	2021-04-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209501-003	PED	2021-04-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209501-001	PED	2021-04-11	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209501-002	PED	2021-04-11	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209501-003	PED	2021-04-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209501-001	PED	2021-04-11	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N209501-002	PED	2021-04-11	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N209501-003	PED	2021-04-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209501-001	NP	2020-10-11	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N209501-001	PED	2021-04-11	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N209501-002	NP	2020-10-11	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N209501-002	PED	2021-04-11	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N209501-003	NP	2020-10-11	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N209501-003	PED	2021-04-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209501-001	NP	2020-10-11	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N209501-001	PED	2021-04-11	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N209501-002	NP	2020-10-11	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N209501-002	PED	2021-04-11	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N209501-003	NP	2020-10-11	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N209501-003	PED	2021-04-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209501-001	NP	2020-10-11	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N209501-001	PED	2021-04-11	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N209501-002	NP	2020-10-11	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N209501-002	PED	2021-04-11	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N209501-003	NP	2020-10-11	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N209501-003	PED	2021-04-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209501-001	NP	2020-10-11	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N209501-001	PED	2021-04-11	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N209501-002	NP	2020-10-11	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N209501-002	PED	2021-04-11	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N209501-003	NP	2020-10-11	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N209501-003	PED	2021-04-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209501-001	NP	2020-10-11	`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
Lyrica CR	PREGABALIN	Viatris Specialty LLC	f280bbd8-2af2-444a-bd96-e409337ca6dd	2026-03-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209501 application number: NDA209501

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0071-1026	Lyrica CR	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1026	Lyrica CR	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1026	Lyrica CR	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1026	Lyrica CR	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1027	Lyrica CR	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1027	Lyrica CR	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1027	Lyrica CR	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1027	Lyrica CR	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1029	Lyrica CR	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1029	Lyrica CR	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1029	Lyrica CR	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-1029	Lyrica CR	PREGABALIN	Parke-Davis Div of Pfizer Inc	NDA	Current
63539-024	Lyrica CR	PREGABALIN	U.S. Pharmaceuticals	NDA	Current
63539-024	Lyrica CR	PREGABALIN	U.S. Pharmaceuticals	NDA	Current
63539-024	Lyrica CR	PREGABALIN	U.S. Pharmaceuticals	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82105	SUPPL	2025-05-01
82060	SUPPL	2025-04-29
82059	SUPPL	2025-04-29
76825	SUPPL	2024-04-10
76793	SUPPL	2024-01-08
62517	SUPPL	2020-04-09
62445	SUPPL	2020-04-06
56106	ORIG	2018-10-26
50021	ORIG	2017-10-12
50018	ORIG	2017-10-12
50017	ORIG	2017-10-12