Application 206912

Type: ANDA
Sponsor: HETERO LABS LTD III

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PREGABALIN	PREGABALIN	CAPSULE;ORAL	25MG	No	No
002	PREGABALIN	PREGABALIN	CAPSULE;ORAL	50MG	No	No
003	PREGABALIN	PREGABALIN	CAPSULE;ORAL	75MG	No	No
004	PREGABALIN	PREGABALIN	CAPSULE;ORAL	100MG	No	No
005	PREGABALIN	PREGABALIN	CAPSULE;ORAL	150MG	No	No
006	PREGABALIN	PREGABALIN	CAPSULE;ORAL	200MG	No	No
007	PREGABALIN	PREGABALIN	CAPSULE;ORAL	225MG	No	No
008	PREGABALIN	PREGABALIN	CAPSULE;ORAL	300MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A206912-001	PREGABALIN	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-10-08
A206912-002	PREGABALIN	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-10-08
A206912-003	PREGABALIN	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-10-08
A206912-004	PREGABALIN	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-10-08
A206912-005	PREGABALIN	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-10-08
A206912-006	PREGABALIN	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-10-08
A206912-007	PREGABALIN	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-10-08
A206912-008	PREGABALIN	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-10-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 8 matching rows.

Application-product, TE code table
Application-product	TE code
A206912-001	AB
A206912-002	AB
A206912-003	AB
A206912-004	AB
A206912-005	AB
A206912-006	AB
A206912-007	AB
A206912-008	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.

Product history page 1 of 9 · 328 observed 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	A206912-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-10-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206912-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-10-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206912-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-10-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206912-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-10-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206912-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-10-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206912-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-10-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206912-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-10-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206912-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-10-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206912-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-10-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206912-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-10-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206912-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-10-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206912-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-10-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206912-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-10-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206912-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-10-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206912-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-10-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206912-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-10-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206912-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206912-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206912-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206912-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206912-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206912-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206912-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206912-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-10-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206912-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206912-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206912-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206912-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206912-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206912-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206912-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206912-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-10-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206912-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206912-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206912-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206912-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206912-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206912-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206912-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206912-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-10-08	`6a471c1ec25d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 9 · 328 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A206912-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206912-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206912-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206912-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206912-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206912-006	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206912-007	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206912-008	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206912-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206912-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206912-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206912-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206912-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206912-006	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206912-007	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206912-008	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206912-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206912-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206912-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206912-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206912-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206912-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206912-007	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206912-008	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206912-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206912-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206912-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206912-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206912-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206912-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206912-007	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206912-008	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206912-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206912-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206912-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206912-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206912-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206912-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206912-007	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206912-008	AB	1	`6a471c1ec25d…`

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 2 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pregabalin	PREGABALIN	Advanced Rx Pharmacy of Tennessee, LLC	c8acdbcf-3076-63b2-e053-2a95a90aa3c4	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206912 application number: ANDA206912 ndc (product): 80425-0152
Pregabalin	PREGABALIN	Bryant Ranch Prepack	fac0eb4e-12ef-4e8e-8cbe-c43c26f0faee	2024-08-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206912 application number: ANDA206912 ndc (product): 71335-1791
Pregabalin	PREGABALIN	Bryant Ranch Prepack	c72b0bed-b7b4-4ae1-914e-756d76b66ed9	2024-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206912 application number: ANDA206912 ndc (product): 71335-1788
Pregabalin	PREGABALIN	Bryant Ranch Prepack	aac1f2f4-5ef5-49dd-b914-54f2cf2b1bc1	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206912 application number: ANDA206912 ndc (product): 71335-1789
Pregabalin	PREGABALIN	Bryant Ranch Prepack	b2d45d41-a787-4912-962d-0bd98b70d58a	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206912 application number: ANDA206912 ndc (product): 71335-1822
Pregabalin	PREGABALIN	Bryant Ranch Prepack	616b37d6-93d5-44de-a993-bddf59eaee9a	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206912 application number: ANDA206912 ndc (product): 71335-1792

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 33 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
31722-610	Pregabalin	Pregabalin	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-611	Pregabalin	Pregabalin	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-612	Pregabalin	Pregabalin	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-613	Pregabalin	Pregabalin	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-614	Pregabalin	Pregabalin	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-615	Pregabalin	Pregabalin	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-616	Pregabalin	Pregabalin	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-617	Pregabalin	Pregabalin	Camber Pharmaceuticals, Inc.	ANDA	Current
71335-1788	Pregabalin	Pregabalin	Bryant Ranch Prepack	ANDA	Current
71335-1788	Pregabalin	Pregabalin	Bryant Ranch Prepack	ANDA	Current
71335-1789	Pregabalin	Pregabalin	Bryant Ranch Prepack	ANDA	Current
71335-1789	Pregabalin	Pregabalin	Bryant Ranch Prepack	ANDA	Current
71335-1789	Pregabalin	Pregabalin	Bryant Ranch Prepack	ANDA	Current
71335-1790	Pregabalin	Pregabalin	Bryant Ranch Prepack	ANDA	Current
71335-1790	Pregabalin	Pregabalin	Bryant Ranch Prepack	ANDA	Current
71335-1790	Pregabalin	Pregabalin	Bryant Ranch Prepack	ANDA	Current
71335-1791	Pregabalin	Pregabalin	Bryant Ranch Prepack	ANDA	Current
71335-1791	Pregabalin	Pregabalin	Bryant Ranch Prepack	ANDA	Current
71335-1792	Pregabalin	Pregabalin	Bryant Ranch Prepack	ANDA	Current
71335-1792	Pregabalin	Pregabalin	Bryant Ranch Prepack	ANDA	Current
71335-1822	Pregabalin	Pregabalin	Bryant Ranch Prepack	ANDA	Current
71335-1822	Pregabalin	Pregabalin	Bryant Ranch Prepack	ANDA	Current
80425-0147	Lyrica	Pregabalin 75mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0147	Pregabalin	Pregabalin	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0147	Pregabalin	Pregabalin	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0152	Lyrica	Pregabalin 50mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0152	Pregabalin	Pregabalin	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0152	Pregabalin	Pregabalin	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0170	Lyrica	Pregabalin 100mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0170	Pregabalin	Pregabalin	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0170	Pregabalin	Pregabalin	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0178	Pregabalin	Pregabalin	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0178	Pregabalin	Pregabalin	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current