Application 011011

Type: NDA
Sponsor: AUXILIUM PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
004	ROBAXIN	METHOCARBAMOL	TABLET;ORAL	500MG	Yes	No
006	ROBAXIN-750	METHOCARBAMOL	TABLET;ORAL	750MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N011011-004	ROBAXIN	METHOCARBAMOL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982
N011011-006	ROBAXIN-750	METHOCARBAMOL	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N011011-004	ROBAXIN	500MG	TABLET / ORAL		RLD, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N011011-006	ROBAXIN-750	750MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N011011-004	ROBAXIN	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N011011-006	ROBAXIN-750	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N011011-004	ROBAXIN	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		RLD, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N011011-006	ROBAXIN-750	750MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		RLD, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N011011-004	ROBAXIN	500MG	TABLET / ORAL		RLD, Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N011011-006	ROBAXIN-750	750MG	TABLET / ORAL		RLD, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N011011-004	ROBAXIN	500MG	TABLET / ORAL		RLD, Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N011011-006	ROBAXIN-750	750MG	TABLET / ORAL		RLD, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N011011-004	ROBAXIN	500MG	TABLET / ORAL		RLD, Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N011011-006	ROBAXIN-750	750MG	TABLET / ORAL		RLD, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N011011-004	ROBAXIN	500MG	TABLET / ORAL		RLD, Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N011011-006	ROBAXIN-750	750MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N011011-004	ROBAXIN	500MG	TABLET / ORAL		RLD, Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N011011-006	ROBAXIN-750	750MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N011011-004	ROBAXIN	500MG	TABLET / ORAL		RLD, Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N011011-006	ROBAXIN-750	750MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N011011-004	ROBAXIN	500MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N011011-006	ROBAXIN-750	750MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N011011-004	ROBAXIN	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N011011-006	ROBAXIN-750	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N011011-004	ROBAXIN	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N011011-006	ROBAXIN-750	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N011011-004	ROBAXIN	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N011011-006	ROBAXIN-750	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N011011-004	ROBAXIN	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N011011-006	ROBAXIN-750	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N011011-004	ROBAXIN	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N011011-006	ROBAXIN-750	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N011011-004	ROBAXIN	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N011011-006	ROBAXIN-750	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N011011-004	ROBAXIN	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N011011-006	ROBAXIN-750	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N011011-004	ROBAXIN	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N011011-006	ROBAXIN-750	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N011011-004	ROBAXIN	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N011011-006	ROBAXIN-750	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N011011-004	ROBAXIN	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N011011-006	ROBAXIN-750	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N011011-006	AA	1	`74a2ff9319b5…`
2020-11-12 02:37 UTC	2020-11	N011011-006	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N011011-006	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N011011-006	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N011011-004	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N011011-006	AA	1	`ea99ee380514…`

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 8 · 141 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methocarbamol	METHOCARBAMOL	Cardinal Health 107, LLC	05b287d3-5004-4d8b-9ebe-a96caa2b8d89	2026-08-27	Warnings, Adverse reactions	Name fallback generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	St. Mary's Medical Park Pharmacy	56090def-7caf-e916-e063-6294a90a6ac2	2026-08-05	Warnings, Adverse reactions	Name fallback generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Coupler LLC	5827d07b-a0a4-a543-e063-6294a90ad565	2026-08-03	Warnings, Adverse reactions	Name fallback generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	American Health Packaging	d842fe4e-fc46-4d70-9ca3-b47191672f96	2026-07-30	Warnings, Adverse reactions	Name fallback generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Medcore LLC	1a6b7327-fd42-4de0-bd0d-2dd478502d52	2026-07-29	Warnings, Adverse reactions	Name fallback generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	PD-Rx Pharmaceuticals, Inc.	3d4a2486-863e-4e9f-be3b-67882863e7d4	2026-07-29	Warnings, Adverse reactions	Name fallback generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	PD-Rx Pharmaceuticals, Inc.	6b9ed3a4-46d5-462e-ac93-6b959b314d77	2026-07-29	Warnings, Adverse reactions	Name fallback generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	PD-Rx Pharmaceuticals, Inc.	adb49cb7-8900-44dc-add0-22e2cd8235ac	2026-07-29	Warnings, Adverse reactions	Name fallback generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	PD-Rx Pharmaceuticals, Inc.	0deb5368-ffdc-40fc-a97c-ba89b7a97e50	2026-07-21	Warnings, Adverse reactions	Name fallback generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Unit Dose Solutions, Inc.	5539d4f6-1192-2770-e063-6394a90a1e50	2026-06-27	Warnings, Adverse reactions	Name fallback generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	A-S Medication Solutions	9617e2b0-4255-4542-95ca-9ee1818ca450	2026-06-26	Warnings, Adverse reactions	Name fallback generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	HAWAII REPACK, INC.	8643032a-c491-4ae4-ac46-5e0c4c79dc5b	2026-06-26	Warnings, Adverse reactions	Name fallback generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	A-S Medication Solutions	cfdc0d68-00ad-44d6-b932-819cc3d5d60e	2026-06-26	Warnings, Adverse reactions	Name fallback generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	A-S Medication Solutions	b81a8e64-ae41-409b-94a6-b36cb50bc25d	2026-06-26	Warnings, Adverse reactions	Name fallback generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	HAWAII REPACK, INC.	c4744824-4c74-411d-aa8e-c63ee9d89913	2026-06-25	Warnings, Adverse reactions	Name fallback generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Preferred Pharmaceuticals Inc.	4ef1c2c0-31e1-4f85-b645-ff47a057a994	2026-06-23	Warnings, Adverse reactions	Name fallback generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Preferred Pharmaceuticals, Inc	425abc3b-2111-4fac-bf27-b685d1e657af	2026-06-23	Warnings, Adverse reactions	Name fallback generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Direct_rx	4c5c8933-a4b5-f9c2-e063-6294a90a6f00	2026-06-16	Warnings, Adverse reactions	Name fallback generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Bryant Ranch Prepack	5af36a83-2b36-4fe2-8c6a-61b551621421	2026-06-16	Warnings, Adverse reactions	Name fallback generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Bryant Ranch Prepack	cc004f5c-d5fc-48c5-9f37-c59b9c37e113	2026-06-16	Warnings, Adverse reactions	Name fallback generic name: METHOCARBAMOL

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
52244-429	Robaxin	Methocarbamol	Endo Pharmaceuticals, Inc.	NDA	Current
52244-449	Robaxin	Methocarbamol	Endo Pharmaceuticals, Inc.	NDA	Current
52244-449	Robaxin	Methocarbamol	Endo Pharmaceuticals Inc.	NDA	Current
52244-449	Robaxin	Methocarbamol	Endo Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
63487	SUPPL	2020-06-12
57893	SUPPL	2019-03-05
11919	SUPPL	2003-05-16
248	SUPPL	2003-05-16
33034	SUPPL	2003-05-06
10756	SUPPL	2003-05-06