Application 209102

Type: ANDA
Sponsor: RUBICON

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BACLOFEN	BACLOFEN	TABLET;ORAL	5MG	No	No
002	BACLOFEN	BACLOFEN	TABLET;ORAL	10MG	No	No
003	BACLOFEN	BACLOFEN	TABLET;ORAL	20MG	No	No
004	BACLOFEN	BACLOFEN	TABLET;ORAL	15MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A209102-001	BACLOFEN	BACLOFEN	5MG	TABLET / ORAL	AB	2017-11-28
A209102-002	BACLOFEN	BACLOFEN	10MG	TABLET / ORAL	AB	2017-11-28
A209102-003	BACLOFEN	BACLOFEN	20MG	TABLET / ORAL	AB	2017-11-28
A209102-004	BACLOFEN	BACLOFEN	15MG	TABLET / ORAL	AB	2024-02-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A209102-001	AB
A209102-002	AB
A209102-003	AB
A209102-004	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 · 148 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
2026-09-14 22:38:34	2026-08	A209102-001	BACLOFEN	5MG	TABLET / ORAL	AB		2017-11-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209102-002	BACLOFEN	10MG	TABLET / ORAL	AB		2017-11-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209102-003	BACLOFEN	20MG	TABLET / ORAL	AB		2017-11-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209102-004	BACLOFEN	15MG	TABLET / ORAL	AB		2024-02-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209102-001	BACLOFEN	5MG	TABLET / ORAL	AB		2017-11-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209102-002	BACLOFEN	10MG	TABLET / ORAL	AB		2017-11-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209102-003	BACLOFEN	20MG	TABLET / ORAL	AB		2017-11-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209102-004	BACLOFEN	15MG	TABLET / ORAL	AB		2024-02-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209102-001	BACLOFEN	5MG	TABLET / ORAL	AB		2017-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209102-002	BACLOFEN	10MG	TABLET / ORAL	AB		2017-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209102-003	BACLOFEN	20MG	TABLET / ORAL	AB		2017-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209102-004	BACLOFEN	15MG	TABLET / ORAL	AB		2024-02-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209102-001	BACLOFEN	5MG	TABLET / ORAL	AB	RS	2017-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209102-002	BACLOFEN	10MG	TABLET / ORAL	AB		2017-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209102-003	BACLOFEN	20MG	TABLET / ORAL	AB		2017-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209102-004	BACLOFEN	15MG	TABLET / ORAL	AB		2024-02-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209102-001	BACLOFEN	5MG	TABLET / ORAL	AB	RS	2017-11-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209102-002	BACLOFEN	10MG	TABLET / ORAL	AB		2017-11-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209102-003	BACLOFEN	20MG	TABLET / ORAL	AB		2017-11-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209102-004	BACLOFEN	15MG	TABLET / ORAL	AB		2024-02-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209102-001	BACLOFEN	5MG	TABLET / ORAL	AB	RS	2017-11-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209102-002	BACLOFEN	10MG	TABLET / ORAL	AB		2017-11-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209102-003	BACLOFEN	20MG	TABLET / ORAL	AB		2017-11-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209102-004	BACLOFEN	15MG	TABLET / ORAL	AB		2024-02-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209102-001	BACLOFEN	5MG	TABLET / ORAL	AB	RS	2017-11-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209102-002	BACLOFEN	10MG	TABLET / ORAL	AB		2017-11-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209102-003	BACLOFEN	20MG	TABLET / ORAL	AB		2017-11-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209102-004	BACLOFEN	15MG	TABLET / ORAL	AB		2024-02-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209102-001	BACLOFEN	5MG	TABLET / ORAL	AB	RS	2017-11-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209102-002	BACLOFEN	10MG	TABLET / ORAL	AB		2017-11-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209102-003	BACLOFEN	20MG	TABLET / ORAL	AB		2017-11-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209102-004	BACLOFEN	15MG	TABLET / ORAL	AB		2024-02-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209102-001	BACLOFEN	5MG	TABLET / ORAL	AB	RS	2017-11-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209102-002	BACLOFEN	10MG	TABLET / ORAL	AB		2017-11-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209102-003	BACLOFEN	20MG	TABLET / ORAL	AB		2017-11-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209102-004	BACLOFEN	15MG	TABLET / ORAL	AB		2024-02-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209102-001	BACLOFEN	5MG	TABLET / ORAL	AB	RS	2017-11-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209102-002	BACLOFEN	10MG	TABLET / ORAL	AB		2017-11-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209102-003	BACLOFEN	20MG	TABLET / ORAL	AB		2017-11-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209102-004	BACLOFEN	15MG	TABLET / ORAL	AB		2024-02-05	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 143 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	A209102-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209102-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209102-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209102-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209102-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209102-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209102-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209102-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209102-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209102-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209102-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209102-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209102-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209102-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209102-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209102-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209102-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209102-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209102-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209102-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209102-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209102-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209102-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209102-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209102-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209102-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209102-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209102-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209102-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209102-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209102-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209102-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209102-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209102-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209102-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209102-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209102-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209102-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209102-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209102-004	AB	1	`5bbf6a4d5a75…`

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 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BACLOFEN	BACLOFEN	Bryant Ranch Prepack	9834e409-8633-4f99-8ac7-7fa298d01c44	2024-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209102 application number: ANDA209102
BACLOFEN	BACLOFEN	Bryant Ranch Prepack	adc072b9-e48b-470d-9eb1-fd7b52c1f122	2024-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209102 application number: ANDA209102 ndc (product): 71335-0949
BACLOFEN	BACLOFEN	TruPharma LLC	68aa591e-ea98-4438-9a4a-4f7e9ea2b285	2024-04-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209102 application number: ANDA209102 ndc (product): 52817-321 ndc (product): 52817-320 ndc (product): 52817-319
BACLOFEN	BACLOFEN	NCS HealthCare of KY, LLC dba Vangard Labs	2927228a-7a3e-4e1d-ab5f-4407b00f6899	2023-05-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209102 application number: ANDA209102

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
17856-0319	BACLOFEN	BACLOFEN	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
52817-319	BACLOFEN	BACLOFEN	TruPharma LLC	ANDA	Current
52817-319	BACLOFEN	BACLOFEN	TruPharma LLC	ANDA	Current
52817-319	BACLOFEN	baclofen	TruPharma LLC	ANDA	Current
52817-320	BACLOFEN	BACLOFEN	TruPharma LLC	ANDA	Current
52817-320	BACLOFEN	BACLOFEN	TruPharma LLC	ANDA	Current
52817-320	BACLOFEN	baclofen	TruPharma LLC	ANDA	Current
52817-321	BACLOFEN	BACLOFEN	TruPharma LLC	ANDA	Current
52817-321	BACLOFEN	BACLOFEN	TruPharma LLC	ANDA	Current
52817-321	BACLOFEN	baclofen	TruPharma LLC	ANDA	Current
70518-3614	BACLOFEN	BACLOFEN	REMEDYREPACK INC.	ANDA	Current
70934-918	BACLOFEN	BACLOFEN	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-918	BACLOFEN	BACLOFEN	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-918	BACLOFEN	BACLOFEN	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71335-0949	BACLOFEN	baclofen	Bryant Ranch Prepack	ANDA	Current
71335-0949	BACLOFEN	BACLOFEN	Bryant Ranch Prepack	ANDA	Current
71335-0949	BACLOFEN	BACLOFEN	Bryant Ranch Prepack	ANDA	Current
72888-009	BACLOFEN	BACLOFEN	Advagen Pharma Limited	ANDA	Current
72888-009	BACLOFEN	BACLOFEN	Advagen Pharma Limited	ANDA	Current
72888-009	BACLOFEN	BACLOFEN	Advagen Pharma Limited	ANDA	Current
72888-009	BACLOFEN	BACLOFEN	Advagen Pharma Limited	ANDA	Current
72888-010	BACLOFEN	BACLOFEN	Advagen Pharma Limited	ANDA	Current
72888-010	BACLOFEN	BACLOFEN	Advagen Pharma Limited	ANDA	Current
72888-010	BACLOFEN	BACLOFEN	Advagen Pharma Limited	ANDA	Current
72888-010	BACLOFEN	BACLOFEN	Advagen Pharma Limited	ANDA	Current
72888-011	BACLOFEN	BACLOFEN	Advagen Pharma Limited	ANDA	Current
72888-011	BACLOFEN	BACLOFEN	Advagen Pharma Limited	ANDA	Current
72888-011	BACLOFEN	BACLOFEN	Advagen Pharma Limited	ANDA	Current
72888-011	BACLOFEN	BACLOFEN	Advagen Pharma Limited	ANDA	Current
80425-0157	Baclofen	Baclofen 20mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0157	Baclofen	Baclofen	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0157	Baclofen	Baclofen	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0157	Baclofen	Baclofen	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
50740	ORIG	2017-12-18