Application 215885

Type: ANDA
Sponsor: MANKIND PHARMA

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	Approval date
A215885-001	BACLOFEN	BACLOFEN	5MG	TABLET / ORAL	AB	2022-01-25
A215885-002	BACLOFEN	BACLOFEN	10MG	TABLET / ORAL	AB	2022-01-25
A215885-003	BACLOFEN	BACLOFEN	20MG	TABLET / ORAL	AB	2022-01-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215885-001	AB
A215885-002	AB
A215885-003	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 3 · 99 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
2026-08-18 06:07:40	2026-07	A215885-001	BACLOFEN	5MG	TABLET / ORAL	AB	2022-01-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215885-002	BACLOFEN	10MG	TABLET / ORAL	AB	2022-01-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215885-003	BACLOFEN	20MG	TABLET / ORAL	AB	2022-01-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215885-001	BACLOFEN	5MG	TABLET / ORAL	AB	2022-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215885-002	BACLOFEN	10MG	TABLET / ORAL	AB	2022-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215885-003	BACLOFEN	20MG	TABLET / ORAL	AB	2022-01-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215885-001	BACLOFEN	5MG	TABLET / ORAL	AB	2022-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215885-002	BACLOFEN	10MG	TABLET / ORAL	AB	2022-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215885-003	BACLOFEN	20MG	TABLET / ORAL	AB	2022-01-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215885-001	BACLOFEN	5MG	TABLET / ORAL	AB	2022-01-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215885-002	BACLOFEN	10MG	TABLET / ORAL	AB	2022-01-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215885-003	BACLOFEN	20MG	TABLET / ORAL	AB	2022-01-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215885-001	BACLOFEN	5MG	TABLET / ORAL	AB	2022-01-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215885-002	BACLOFEN	10MG	TABLET / ORAL	AB	2022-01-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215885-003	BACLOFEN	20MG	TABLET / ORAL	AB	2022-01-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215885-001	BACLOFEN	5MG	TABLET / ORAL	AB	2022-01-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215885-002	BACLOFEN	10MG	TABLET / ORAL	AB	2022-01-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215885-003	BACLOFEN	20MG	TABLET / ORAL	AB	2022-01-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215885-001	BACLOFEN	5MG	TABLET / ORAL	AB	2022-01-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215885-002	BACLOFEN	10MG	TABLET / ORAL	AB	2022-01-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215885-003	BACLOFEN	20MG	TABLET / ORAL	AB	2022-01-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215885-001	BACLOFEN	5MG	TABLET / ORAL	AB	2022-01-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215885-002	BACLOFEN	10MG	TABLET / ORAL	AB	2022-01-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215885-003	BACLOFEN	20MG	TABLET / ORAL	AB	2022-01-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215885-001	BACLOFEN	5MG	TABLET / ORAL	AB	2022-01-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215885-002	BACLOFEN	10MG	TABLET / ORAL	AB	2022-01-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215885-003	BACLOFEN	20MG	TABLET / ORAL	AB	2022-01-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215885-001	BACLOFEN	5MG	TABLET / ORAL	AB	2022-01-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215885-002	BACLOFEN	10MG	TABLET / ORAL	AB	2022-01-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215885-003	BACLOFEN	20MG	TABLET / ORAL	AB	2022-01-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215885-001	BACLOFEN	5MG	TABLET / ORAL	AB	2022-01-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215885-002	BACLOFEN	10MG	TABLET / ORAL	AB	2022-01-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215885-003	BACLOFEN	20MG	TABLET / ORAL	AB	2022-01-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215885-001	BACLOFEN	5MG	TABLET / ORAL	AB	2022-01-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215885-002	BACLOFEN	10MG	TABLET / ORAL	AB	2022-01-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215885-003	BACLOFEN	20MG	TABLET / ORAL	AB	2022-01-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215885-001	BACLOFEN	5MG	TABLET / ORAL	AB	2022-01-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215885-002	BACLOFEN	10MG	TABLET / ORAL	AB	2022-01-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215885-003	BACLOFEN	20MG	TABLET / ORAL	AB	2022-01-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215885-001	BACLOFEN	5MG	TABLET / ORAL	AB	2022-01-25	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 99 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A215885-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215885-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215885-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215885-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215885-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215885-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215885-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215885-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215885-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215885-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215885-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215885-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215885-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215885-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215885-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215885-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215885-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215885-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215885-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215885-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215885-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215885-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215885-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215885-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215885-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215885-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215885-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215885-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215885-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215885-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215885-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215885-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215885-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215885-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215885-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215885-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215885-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215885-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215885-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215885-001	AB	1	`1e350fbaab3a…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Baclofen	BACLOFEN	REMEDYREPACK INC.	ebbfec9e-621c-4d04-8a1c-81d2eb9e9c74	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215885 application number: ANDA215885
Baclofen	BACLOFEN	Golden State Medical Supply, Inc.	32336e92-89a4-7d7f-e063-6394a90ae924	2026-04-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215885 application number: ANDA215885
BACLOFEN	BACLOFEN	Cardinal Health 107, LLC	a0cdf5e0-45cb-41e0-a6f1-6e3aaf02b67c	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215885 application number: ANDA215885
Baclofen	BACLOFEN	Lifestar Pharma LLC	f9dd1b55-2984-446a-8146-2ab0f5211e15	2026-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215885 application number: ANDA215885 ndc (product): 70756-288 ndc (product): 70756-085 ndc (product): 70756-289
BACLOFEN	BACLOFEN	Major Pharmaceuticals	f328296e-0713-4acb-bcb5-c10d7838d380	2025-10-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215885 application number: ANDA215885
Baclofen	BACLOFEN	Aphena Pharma Solutions - Tennessee, LLC	39ad22ca-f034-f605-e063-6294a90a08e4	2025-07-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215885 application number: ANDA215885
Baclofen	BACLOFEN	Aphena Pharma Solutions - Tennessee, LLC	3981db3e-672c-1634-e063-6294a90a4cd1	2025-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215885 application number: ANDA215885
Baclofen	BACLOFEN	NCS HealthCare of KY, LLC dba Vangard Labs	ea4ad5c5-207c-4a68-8e6e-4ff101777e5c	2024-10-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215885 application number: ANDA215885

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70756-085	Baclofen	Baclofen	Lifestar Pharma LLC	ANDA	Current
70756-288	Baclofen	Baclofen	Lifestar Pharma LLC	ANDA	Current
70756-289	Baclofen	Baclofen	Lifestar Pharma LLC	ANDA	Current