Application 020235

Type: NDA
Sponsor: PFIZER PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NEURONTIN	GABAPENTIN	CAPSULE;ORAL	100MG	Yes	No
002	NEURONTIN	GABAPENTIN	CAPSULE;ORAL	300MG	Yes	No
003	NEURONTIN	GABAPENTIN	CAPSULE;ORAL	400MG	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
N020235-001	NEURONTIN	GABAPENTIN	100MG	CAPSULE / ORAL	AB	RLD	1993-12-30
N020235-002	NEURONTIN	GABAPENTIN	300MG	CAPSULE / ORAL	AB	RLD	1993-12-30
N020235-003	NEURONTIN	GABAPENTIN	400MG	CAPSULE / ORAL	AB	RLD, RS	1993-12-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020235-001	AB
N020235-002	AB
N020235-003	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 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	N020235-001	NEURONTIN	100MG	CAPSULE / ORAL	AB	RLD	1993-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020235-002	NEURONTIN	300MG	CAPSULE / ORAL	AB	RLD	1993-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020235-003	NEURONTIN	400MG	CAPSULE / ORAL	AB	RLD, RS	1993-12-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020235-001	NEURONTIN	100MG	CAPSULE / ORAL	AB	RLD	1993-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020235-002	NEURONTIN	300MG	CAPSULE / ORAL	AB	RLD	1993-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020235-003	NEURONTIN	400MG	CAPSULE / ORAL	AB	RLD, RS	1993-12-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020235-001	NEURONTIN	100MG	CAPSULE / ORAL	AB	RLD	1993-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020235-002	NEURONTIN	300MG	CAPSULE / ORAL	AB	RLD	1993-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020235-003	NEURONTIN	400MG	CAPSULE / ORAL	AB	RLD, RS	1993-12-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020235-001	NEURONTIN	100MG	CAPSULE / ORAL	AB	RLD	1993-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020235-002	NEURONTIN	300MG	CAPSULE / ORAL	AB	RLD	1993-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020235-003	NEURONTIN	400MG	CAPSULE / ORAL	AB	RLD, RS	1993-12-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020235-001	NEURONTIN	100MG	CAPSULE / ORAL	AB	RLD	1993-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020235-002	NEURONTIN	300MG	CAPSULE / ORAL	AB	RLD	1993-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020235-003	NEURONTIN	400MG	CAPSULE / ORAL	AB	RLD, RS	1993-12-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020235-001	NEURONTIN	100MG	CAPSULE / ORAL	AB	RLD	1993-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020235-002	NEURONTIN	300MG	CAPSULE / ORAL	AB	RLD	1993-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020235-003	NEURONTIN	400MG	CAPSULE / ORAL	AB	RLD, RS	1993-12-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020235-001	NEURONTIN	100MG	CAPSULE / ORAL	AB	RLD	1993-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020235-002	NEURONTIN	300MG	CAPSULE / ORAL	AB	RLD	1993-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020235-003	NEURONTIN	400MG	CAPSULE / ORAL	AB	RLD, RS	1993-12-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020235-001	NEURONTIN	100MG	CAPSULE / ORAL	AB	RLD	1993-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020235-002	NEURONTIN	300MG	CAPSULE / ORAL	AB	RLD	1993-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020235-003	NEURONTIN	400MG	CAPSULE / ORAL	AB	RLD, RS	1993-12-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020235-001	NEURONTIN	100MG	CAPSULE / ORAL	AB	RLD	1993-12-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020235-002	NEURONTIN	300MG	CAPSULE / ORAL	AB	RLD	1993-12-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020235-003	NEURONTIN	400MG	CAPSULE / ORAL	AB	RLD, RS	1993-12-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020235-001	NEURONTIN	100MG	CAPSULE / ORAL	AB	RLD	1993-12-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020235-002	NEURONTIN	300MG	CAPSULE / ORAL	AB	RLD	1993-12-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020235-003	NEURONTIN	400MG	CAPSULE / ORAL	AB	RLD, RS	1993-12-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020235-001	NEURONTIN	100MG	CAPSULE / ORAL	AB	RLD	1993-12-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020235-002	NEURONTIN	300MG	CAPSULE / ORAL	AB	RLD	1993-12-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020235-003	NEURONTIN	400MG	CAPSULE / ORAL	AB	RLD, RS	1993-12-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020235-001	NEURONTIN	100MG	CAPSULE / ORAL	AB	RLD	1993-12-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020235-002	NEURONTIN	300MG	CAPSULE / ORAL	AB	RLD	1993-12-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020235-003	NEURONTIN	400MG	CAPSULE / ORAL	AB	RLD, RS	1993-12-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020235-001	NEURONTIN	100MG	CAPSULE / ORAL	AB	RLD	1993-12-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020235-002	NEURONTIN	300MG	CAPSULE / ORAL	AB	RLD	1993-12-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020235-003	NEURONTIN	400MG	CAPSULE / ORAL	AB	RLD, RS	1993-12-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020235-001	NEURONTIN	100MG	CAPSULE / ORAL	AB	RLD	1993-12-30	`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	N020235-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020235-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020235-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020235-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020235-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020235-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020235-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020235-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020235-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020235-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020235-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020235-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020235-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020235-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020235-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020235-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020235-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020235-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020235-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020235-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020235-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020235-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020235-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020235-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020235-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020235-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020235-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020235-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020235-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020235-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020235-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020235-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020235-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020235-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020235-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020235-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020235-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020235-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020235-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020235-001	AB	1	`8072bd15b7f6…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Neurontin	GABAPENTIN	Viatris Specialty LLC	97935fd9-1d4a-43b6-a5d9-de994591187b	2026-05-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020235 application number: NDA020235
Neurontin	GABAPENTIN	Parke-Davis Div of Pfizer Inc	ee9ad9ed-6d9f-4ee1-9d7f-cfad438df388	2022-07-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020235 application number: NDA020235 ndc (product): 0071-0803 ndc (product): 0071-0806 ndc (product): 0071-0805

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 40 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0071-0803	Neurontin	gabapentin	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-0803	Neurontin	gabapentin	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-0803	Neurontin	gabapentin	Parke-Davis Div of Pfizer	NDA	Current
0071-0803	Neurontin	gabapentin	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-0803	Neurontin	gabapentin	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-0803	Neurontin	gabapentin	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-0803	Neurontin	gabapentin	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-0805	Neurontin	gabapentin	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-0805	Neurontin	gabapentin	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-0805	Neurontin	gabapentin	Parke-Davis Div of Pfizer	NDA	Current
0071-0805	Neurontin	gabapentin	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-0805	Neurontin	gabapentin	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-0805	Neurontin	gabapentin	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-0805	Neurontin	gabapentin	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-0806	Neurontin	gabapentin	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-0806	Neurontin	gabapentin	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-0806	Neurontin	gabapentin	Parke-Davis Div of Pfizer	NDA	Current
0071-0806	Neurontin	gabapentin	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-0806	Neurontin	gabapentin	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-0806	Neurontin	gabapentin	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-0806	Neurontin	gabapentin	Parke-Davis Div of Pfizer Inc	NDA	Current
59762-4030	GABAPENTIN	gabapentin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-4030	GABAPENTIN	gabapentin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-4030	GABAPENTIN	gabapentin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-4030	GABAPENTIN	gabapentin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-4030	GABAPENTIN	gabapentin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-4135	GABAPENTIN	gabapentin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-4135	GABAPENTIN	gabapentin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-4135	GABAPENTIN	gabapentin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-4135	GABAPENTIN	gabapentin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-4135	GABAPENTIN	gabapentin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-4240	GABAPENTIN	gabapentin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-4240	GABAPENTIN	gabapentin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-4240	GABAPENTIN	gabapentin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-4240	GABAPENTIN	gabapentin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-4240	GABAPENTIN	gabapentin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
70518-1382	Neurontin	gabapentin	REMEDYREPACK INC.	NDA	Current
70518-1382	Neurontin	gabapentin	REMEDYREPACK INC.	NDA	Current
70518-1405	Neurontin	gabapentin	REMEDYREPACK INC.	NDA	Current
70518-1405	Neurontin	gabapentin	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82118	SUPPL	2025-05-01
82066	SUPPL	2025-04-29
82065	SUPPL	2025-04-25
79102	SUPPL	2024-07-16
79098	SUPPL	2024-07-15
65664	SUPPL	2020-12-21
65663	SUPPL	2020-12-21
65633	SUPPL	2020-12-21
62532	SUPPL	2020-04-10
62432	SUPPL	2020-04-03
50123	SUPPL	2017-10-20
50105	SUPPL	2017-10-19
47754	SUPPL	2017-03-29
47711	SUPPL	2017-03-27
47710	SUPPL	2017-03-27
12348	SUPPL	2015-09-23
2220	SUPPL	2015-09-17
24627	SUPPL	2015-05-11
34408	SUPPL	2015-04-27
34407	SUPPL	2014-08-20
2219	SUPPL	2014-08-20
34406	SUPPL	2013-05-09
34405	SUPPL	2013-05-09
12347	SUPPL	2013-05-09
24626	SUPPL	2013-05-07
24625	SUPPL	2013-05-07
2218	SUPPL	2013-05-07
2217	SUPPL	2011-08-12
34404	SUPPL	2011-08-11
24623	SUPPL	2011-03-07
12345	SUPPL	2011-03-04
24624	SUPPL	2010-10-13
12346	SUPPL	2010-10-11
2216	SUPPL	2009-05-01
34403	SUPPL	2009-04-28
2215	SUPPL	2006-05-05
12344	SUPPL	2005-02-23
2214	SUPPL	2005-02-23
2213	SUPPL	2004-06-10
41221	SUPPL	2004-05-06
2212	SUPPL	2002-01-30
24622	SUPPL	2000-10-12
12343	SUPPL	2000-10-12
41220	SUPPL	1998-09-29
34402	SUPPL	1998-09-29
24621	SUPPL	1998-09-29