Application 208193

Type: NDA
Sponsor: METACEL PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OZOBAX	BACLOFEN	SOLUTION;ORAL	5MG/5ML	Yes	Yes
002	OZOBAX DS	BACLOFEN	SOLUTION;ORAL	10MG/5ML	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N208193-001	OZOBAX	BACLOFEN	5MG/5ML	SOLUTION / ORAL		RLD	2019-09-18
N208193-002	OZOBAX DS	BACLOFEN	10MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2023-10-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N208193-002	AA

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208193-001	10610502	2039-08-30	U-2779		2020-04-23

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 2 · 59 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
2026-08-18 06:07:40	2026-07	N208193-001	OZOBAX	5MG/5ML	SOLUTION / ORAL		RLD	2019-09-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208193-002	OZOBAX DS	10MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2023-10-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208193-001	OZOBAX	5MG/5ML	SOLUTION / ORAL		RLD	2019-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208193-002	OZOBAX DS	10MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2023-10-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208193-001	OZOBAX	5MG/5ML	SOLUTION / ORAL		RLD	2019-09-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208193-002	OZOBAX DS	10MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2023-10-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208193-001	OZOBAX	5MG/5ML	SOLUTION / ORAL		RLD	2019-09-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208193-002	OZOBAX DS	10MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2023-10-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208193-001	OZOBAX	5MG/5ML	SOLUTION / ORAL		RLD	2019-09-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208193-002	OZOBAX DS	10MG/5ML	SOLUTION / ORAL		RLD, RS	2023-10-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208193-001	OZOBAX	5MG/5ML	SOLUTION / ORAL		RLD	2019-09-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208193-002	OZOBAX DS	10MG/5ML	SOLUTION / ORAL		RLD, RS	2023-10-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208193-001	OZOBAX	5MG/5ML	SOLUTION / ORAL		RLD	2019-09-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208193-002	OZOBAX DS	10MG/5ML	SOLUTION / ORAL		RLD, RS	2023-10-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208193-001	OZOBAX	5MG/5ML	SOLUTION / ORAL		RLD	2019-09-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208193-002	OZOBAX DS	10MG/5ML	SOLUTION / ORAL		RLD, RS	2023-10-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208193-001	OZOBAX	5MG/5ML	SOLUTION / ORAL		RLD	2019-09-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208193-002	OZOBAX DS	10MG/5ML	SOLUTION / ORAL		RLD, RS	2023-10-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208193-001	OZOBAX	5MG/5ML	SOLUTION / ORAL		RLD	2019-09-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208193-002	OZOBAX DS	10MG/5ML	SOLUTION / ORAL		RLD, RS	2023-10-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208193-001	OZOBAX	5MG/5ML	SOLUTION / ORAL		RLD	2019-09-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208193-002	OZOBAX DS	10MG/5ML	SOLUTION / ORAL		RLD, RS	2023-10-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208193-001	OZOBAX	5MG/5ML	SOLUTION / ORAL		RLD	2019-09-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208193-002	OZOBAX DS	10MG/5ML	SOLUTION / ORAL		RLD, RS	2023-10-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208193-001	OZOBAX	5MG/5ML	SOLUTION / ORAL		RLD	2019-09-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208193-002	OZOBAX DS	10MG/5ML	SOLUTION / ORAL		RLD, RS	2023-10-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208193-001	OZOBAX	5MG/5ML	SOLUTION / ORAL		RLD	2019-09-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208193-002	OZOBAX DS	10MG/5ML	SOLUTION / ORAL		RLD, RS	2023-10-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208193-001	OZOBAX	5MG/5ML	SOLUTION / ORAL		RLD	2019-09-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N208193-002	OZOBAX DS	10MG/5ML	SOLUTION / ORAL		RLD, RS	2023-10-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208193-001	OZOBAX	5MG/5ML	SOLUTION / ORAL		RLD, RS	2019-09-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208193-001	OZOBAX	5MG/5ML	SOLUTION / ORAL		RLD, RS	2019-09-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208193-001	OZOBAX	5MG/5ML	SOLUTION / ORAL		RLD, RS	2019-09-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208193-001	OZOBAX	5MG/5ML	SOLUTION / ORAL		RLD, RS	2019-09-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208193-001	OZOBAX	5MG/5ML	SOLUTION / ORAL		RLD, RS	2019-09-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208193-001	OZOBAX	5MG/5ML	SOLUTION / ORAL		RLD, RS	2019-09-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208193-001	OZOBAX	5MG/5ML	SOLUTION / ORAL		RLD, RS	2019-09-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208193-001	OZOBAX	5MG/5ML	SOLUTION / ORAL		RLD, RS	2019-09-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208193-001	OZOBAX	5MG/5ML	SOLUTION / ORAL		RLD, RS	2019-09-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208193-001	OZOBAX	5MG/5ML	SOLUTION / ORAL		RLD, RS	2019-09-18	`c0c555d07b60…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N208193-002	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208193-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208193-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208193-002	AA	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N208193-002	AA	1	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N208193-001	10610502	2039-08-30	U-2779	2020-04-23	`a50c72e98297…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Baclofen	BACLOFEN	Atlantic Biologicals Corp.	50b3e7be-832b-313d-e063-6394a90a5ab4	2026-08-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208193 application number: NDA208193
Baclofen	BACLOFEN	Rosemont Pharmaceuticals LLC	81a539b3-e547-4a62-ad1b-2eedb30be927	2026-08-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208193 application number: NDA208193
OZOBAX DS	BACLOFEN	Rosemont Pharmaceuticals LLC	d8ddcec5-debe-42b4-a803-e65917cc6a54	2026-03-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208193 application number: NDA208193
Baclofen	BACLOFEN	Palmetto Pharmaceuticals Inc.	2422746c-afec-ad30-e063-6394a90a0403	2025-12-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208193 application number: NDA208193
Baclofen	BACLOFEN	TRUPHARMA, LLC	f8ec79c6-da65-4fb6-b6bd-45df0d2a52c7	2023-10-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208193 application number: NDA208193

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68134-401	BACLOFEN	Baclofen	Palmetto Pharmaceuticals Inc.	NDA	Current
68134-401	BACLOFEN	Baclofen	Palmetto Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
69528-301	OZOBAX	Baclofen	Metacel Pharmaceuticals, LLC	NDA	Current
69528-301	OZOBAX	Baclofen	Metacel Pharmaceuticals, LLC	NDA	Current
69528-301	OZOBAX	Baclofen	Metacel Pharmaceuticals, LLC	NDA	Current
69528-301	OZOBAX	Baclofen	Metacel Pharmaceuticals, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81235	SUPPL	2025-02-12
62552	ORIG	2020-04-13
60044	ORIG	2019-09-19
60042	ORIG	2019-09-19