Application 217857

Type: ANDA
Sponsor: AIPING PHARM INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PREGABALIN	PREGABALIN	TABLET, EXTENDED RELEASE;ORAL	330MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A217857-001	PREGABALIN	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB		2025-01-28
A217857-002	PREGABALIN	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB		2026-06-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A217857-001	AB
A217857-002	AB

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A217857-001	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-01-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217857-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2026-06-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217857-001	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-01-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217857-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2026-06-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217857-001	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-01-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217857-001	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-01-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217857-001	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-01-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217857-001	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-01-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217857-001	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-01-28	`b8a1b40f171c…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217857-001	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-01-28	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217857-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2026-06-24	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A217857-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217857-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217857-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217857-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217857-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217857-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217857-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217857-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217857-001	AB	1	`b8a1b40f171c…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217857-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217857-002	AB	1	`a50c72e98297…`

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 12 of 12 · 226 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pregabalin	PREGABALIN	Proficient Rx LP	d58c0808-2ff9-4ce6-9c07-56f723592385	2022-04-01	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Proficient Rx LP	a0f2b8af-0a04-4db0-adb3-d9d9369223d9	2022-04-01	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
PREGABALIN	PREGABALIN	Asclemed USA, Inc.	69b8a843-a3a8-4d76-8418-f48288625030	2020-06-25	Warnings, Adverse reactions	Name fallback brand name: PREGABALIN generic name: PREGABALIN
Lyrica	PREGABALIN	Parke-Davis Div of Pfizer Inc	60185c88-ecfd-46f9-adb9-b97c6b00a553	2020-06-15	Warnings, Adverse reactions	Name fallback generic name: PREGABALIN
PREGABALIN	PREGABALIN	Proficient Rx LP	4624c58f-8f77-48fa-be0f-fca4010cc8ae	2019-10-01	Warnings, Adverse reactions	Name fallback brand name: PREGABALIN generic name: PREGABALIN
PREGABALIN	PREGABALIN	Proficient Rx LP	6022939f-92a8-4cb4-9f04-f237a4d73f6f	2019-10-01	Warnings, Adverse reactions	Name fallback brand name: PREGABALIN generic name: PREGABALIN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.