Application 211384

Type: ANDA
Sponsor: INVAGEN PHARMS

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
A211384-001	PREGABALIN	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19
A211384-002	PREGABALIN	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19
A211384-003	PREGABALIN	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19
A211384-004	PREGABALIN	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19
A211384-005	PREGABALIN	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19
A211384-006	PREGABALIN	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19
A211384-007	PREGABALIN	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19
A211384-008	PREGABALIN	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211384-001	AB
A211384-002	AB
A211384-003	AB
A211384-004	AB
A211384-005	AB
A211384-006	AB
A211384-007	AB
A211384-008	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 · 336 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	A211384-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211384-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211384-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211384-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211384-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211384-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211384-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211384-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211384-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211384-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211384-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211384-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211384-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211384-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211384-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211384-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211384-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211384-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211384-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211384-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211384-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211384-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211384-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211384-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211384-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211384-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211384-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211384-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211384-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211384-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211384-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211384-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211384-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211384-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211384-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211384-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211384-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211384-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211384-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211384-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 9 · 336 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	A211384-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211384-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211384-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211384-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211384-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211384-006	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211384-007	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211384-008	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211384-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211384-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211384-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211384-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211384-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211384-006	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211384-007	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211384-008	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211384-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211384-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211384-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211384-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211384-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211384-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211384-007	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211384-008	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211384-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211384-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211384-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211384-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211384-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211384-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211384-007	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211384-008	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211384-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211384-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211384-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211384-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211384-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211384-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211384-007	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211384-008	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 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	bf710bcf-75ed-4184-b9c3-81cd05a780a4	2025-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211384 application number: ANDA211384 ndc (product): 71610-320 ndc (product): 71610-315 ndc (product): 71610-313 ndc (product): 71610-317 ndc (product): 71610-316 ndc (product): 71610-318 ndc (product): 71610-314 ndc (product): 71610-319
Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	ef7c2e2c-c314-4bfd-a9fa-39f0b0884d34	2025-07-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211384 application number: ANDA211384
Pregabalin	PREGABALIN	Cipla USA, Inc.	17a8087c-579f-42de-ae92-006ea64def2a	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211384 application number: ANDA211384 ndc (product): 69097-956 ndc (product): 69097-954 ndc (product): 69097-958 ndc (product): 69097-957 ndc (product): 69097-955 ndc (product): 69097-959 ndc (product): 69097-962 ndc (product): 69097-961
Pregabalin	PREGABALIN	Exelan Pharmaceuticals Inc.	3fdc6e94-2504-416c-81dd-2db9bc194ebb	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211384 application number: ANDA211384 ndc (product): 76282-574 ndc (product): 76282-572 ndc (product): 76282-571 ndc (product): 76282-575 ndc (product): 76282-569 ndc (product): 76282-570 ndc (product): 76282-573 ndc (product): 76282-568

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 · 41 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-5177	Pregabalin	PREGABALIN	A-S Medication Solutions	ANDA	Current
69097-954	Pregabalin	PREGABALIN	Cipla USA, Inc.	ANDA	Current
69097-954	Pregabalin	PREGABALIN	Cipla USA, Inc.	ANDA	Current
69097-955	Pregabalin	PREGABALIN	Cipla USA, Inc.	ANDA	Current
69097-955	Pregabalin	PREGABALIN	Cipla USA, Inc.	ANDA	Current
69097-956	Pregabalin	PREGABALIN	Cipla USA, Inc.	ANDA	Current
69097-956	Pregabalin	PREGABALIN	Cipla USA, Inc.	ANDA	Current
69097-957	Pregabalin	PREGABALIN	Cipla USA, Inc.	ANDA	Current
69097-957	Pregabalin	PREGABALIN	Cipla USA, Inc.	ANDA	Current
69097-958	Pregabalin	PREGABALIN	Cipla USA, Inc.	ANDA	Current
69097-958	Pregabalin	PREGABALIN	Cipla USA, Inc.	ANDA	Current
69097-959	Pregabalin	PREGABALIN	Cipla USA, Inc.	ANDA	Current
69097-959	Pregabalin	PREGABALIN	Cipla USA, Inc.	ANDA	Current
69097-961	Pregabalin	PREGABALIN	Cipla USA, Inc.	ANDA	Current
69097-961	Pregabalin	PREGABALIN	Cipla USA, Inc.	ANDA	Current
69097-962	Pregabalin	PREGABALIN	Cipla USA, Inc.	ANDA	Current
69097-962	Pregabalin	PREGABALIN	Cipla USA, Inc.	ANDA	Current
71610-313	Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-314	Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-315	Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-316	Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-317	Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-318	Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-319	Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-320	Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
76282-568	Pregabalin	PREGABALIN	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-568	Pregabalin	PREGABALIN	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-569	Pregabalin	PREGABALIN	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-569	Pregabalin	PREGABALIN	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-570	Pregabalin	PREGABALIN	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-570	Pregabalin	PREGABALIN	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-571	Pregabalin	PREGABALIN	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-571	Pregabalin	PREGABALIN	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-572	Pregabalin	PREGABALIN	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-572	Pregabalin	PREGABALIN	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-573	Pregabalin	PREGABALIN	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-573	Pregabalin	PREGABALIN	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-574	Pregabalin	PREGABALIN	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-574	Pregabalin	PREGABALIN	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-575	Pregabalin	PREGABALIN	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-575	Pregabalin	PREGABALIN	Exelan Pharmaceuticals Inc.	ANDA	Current