Application 200958

Type: ANDA
Sponsor: AUSTARPHARMA LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHOCARBAMOL	METHOCARBAMOL	TABLET;ORAL	500MG	No	No
002	METHOCARBAMOL	METHOCARBAMOL	TABLET;ORAL	750MG	No	No
003	METHOCARBAMOL	METHOCARBAMOL	TABLET;ORAL	1GM	No	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
A200958-001	METHOCARBAMOL	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2011-10-21
A200958-002	METHOCARBAMOL	METHOCARBAMOL	750MG	TABLET / ORAL	AA		2011-10-21
A200958-003	METHOCARBAMOL	METHOCARBAMOL	1GM	TABLET / ORAL	AB	RS	2021-12-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200958-001	AA
A200958-002	AA
A200958-003	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 · 115 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	A200958-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2011-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200958-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA		2011-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200958-003	METHOCARBAMOL	1GM	TABLET / ORAL	AB	RS	2021-12-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200958-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2011-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200958-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA		2011-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200958-003	METHOCARBAMOL	1GM	TABLET / ORAL	AB	RS	2021-12-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200958-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2011-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200958-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA		2011-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200958-003	METHOCARBAMOL	1GM	TABLET / ORAL	AB	RS	2021-12-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200958-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2011-10-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200958-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA		2011-10-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200958-003	METHOCARBAMOL	1GM	TABLET / ORAL	AB	RS	2021-12-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200958-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2011-10-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200958-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA		2011-10-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200958-003	METHOCARBAMOL	1GM	TABLET / ORAL	AB	RS	2021-12-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200958-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2011-10-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200958-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA		2011-10-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200958-003	METHOCARBAMOL	1GM	TABLET / ORAL	AB	RS	2021-12-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200958-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2011-10-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200958-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA		2011-10-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200958-003	METHOCARBAMOL	1GM	TABLET / ORAL	AB	RS	2021-12-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200958-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2011-10-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200958-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA		2011-10-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200958-003	METHOCARBAMOL	1GM	TABLET / ORAL	AB	RS	2021-12-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200958-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2011-10-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200958-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA		2011-10-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200958-003	METHOCARBAMOL	1GM	TABLET / ORAL	AB	RS	2021-12-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200958-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2011-10-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200958-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA		2011-10-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200958-003	METHOCARBAMOL	1GM	TABLET / ORAL	AB	RS	2021-12-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200958-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2011-10-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200958-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA		2011-10-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200958-003	METHOCARBAMOL	1GM	TABLET / ORAL	AB	RS	2021-12-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200958-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2011-10-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200958-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA		2011-10-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200958-003	METHOCARBAMOL	1GM	TABLET / ORAL	AB	RS	2021-12-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200958-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2011-10-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200958-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA		2011-10-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200958-003	METHOCARBAMOL	1GM	TABLET / ORAL	AB	RS	2021-12-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200958-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2011-10-21	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 103 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	A200958-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200958-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200958-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200958-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200958-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200958-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200958-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200958-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200958-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200958-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200958-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200958-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200958-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200958-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200958-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200958-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200958-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200958-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200958-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200958-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200958-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200958-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200958-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200958-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200958-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200958-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200958-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200958-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200958-002	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200958-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200958-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200958-002	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200958-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200958-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200958-002	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200958-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200958-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200958-002	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200958-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200958-001	AA	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methocarbamol	METHOCARBAMOL	Misemer Pharmaceutical	e89ae224-ed25-4ae7-e053-2a95a90a9c0e	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200958 application number: ANDA200958 ndc (product): 0276-0510
Methocarbamol	METHOCARBAMOL	Bostal LLC	d8f10211-f96e-4cf3-9b49-986eb51b703d	2026-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200958 application number: ANDA200958 ndc (product): 35561-211 ndc (product): 35561-212
Methocarbamol	METHOCARBAMOL	Oncora Pharma, LLC	440d6c99-8aca-af07-e063-6294a90aee3d	2025-11-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200958 application number: ANDA200958
Methocarbamol	METHOCARBAMOL	Trifluent Pharma LLC	de2e3af9-03ab-4dc8-b480-6866474ad1bd	2025-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200958 application number: ANDA200958
Methocarb 500-EZS	METHOCARBAMOL	PureTek Corporation	383ce408-1085-43e7-944e-957ff2a9d553	2020-11-10	Warnings, Adverse reactions	Exact identifier ndc (product): 59088-724

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 44 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0276-0510	Methocarbamol	Methocarbamol	Misemer Pharmaceutical	ANDA	Current
35561-211	Methocarbamol	Methocarbamol	AustarPharma LLC	ANDA	Current
35561-211	Methocarbamol	Methocarbamol	AustarPharma LLC	ANDA	Current
35561-211	Methocarbamol	Methocarbamol	AustarPharma LLC	ANDA	Current
35561-212	Methocarbamol	Methocarbamol	AustarPharma LLC	ANDA	Current
35561-212	Methocarbamol	Methocarbamol	AustarPharma LLC	ANDA	Current
35561-212	Methocarbamol	Methocarbamol	AustarPharma LLC	ANDA	Current
43353-948	Methocarbamol	Methocarbamol	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-948	Methocarbamol	Methocarbamol	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-949	Methocarbamol	Methocarbamol	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-949	Methocarbamol	Methocarbamol	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
50090-3173	Methocarbamol	Methocarbamol	A-S Medication Solutions	ANDA	Current
50090-3191	Methocarbamol	Methocarbamol	A-S Medication Solutions	ANDA	Current
50090-3192	Methocarbamol	Methocarbamol	A-S Medication Solutions	ANDA	Current
50090-3265	Methocarbamol	Methocarbamol	A-S Medication Solutions	ANDA	Current
50090-3281	Methocarbamol	Methocarbamol	A-S Medication Solutions	ANDA	Current
50090-3391	Methocarbamol	Methocarbamol	A-S Medication Solutions	ANDA	Current
55700-630	Methocarbamol	Methocarbamol	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
59088-724	Methocarb 500-EZS	Methocarbamol	PureTek Corporation	ANDA	Current
60429-118	Methocarbamol	Methocarbamol	Golden State Medical Supply Inc.	ANDA	Current
60429-118	Methocarbamol	Methocarbamol	Golden State Medical Supply	ANDA	Current
60429-118	Methocarbamol	Methocarbamol	Golden State Medical Supply, Inc.	ANDA	Current
60429-119	Methocarbamol	Methocarbamol	Golden State Medical Supply Inc.	ANDA	Current
60429-119	Methocarbamol	Methocarbamol	Golden State Medical Supply	ANDA	Current
60429-119	Methocarbamol	Methocarbamol	Golden State Medical Supply, Inc.	ANDA	Current
61919-354	ROBAXIN	METHOCARBAMOL	DIRECT RX	ANDA	Current
61919-627	METHOCARBAMOL	METHOCARBAMOL	DirectRX	ANDA	Current
61919-627	METHOCARBAMOL	METHOCARBAMOL	DirectRX	ANDA	Current
61919-627	METHOCARBAMOL	METHOCARBAMOL	DirectRX	ANDA	Current
63187-369	Methocarbamol	Methocarbamol	Proficient Rx LP	ANDA	Current
68071-1874	Methocarbamol	Methocarbamol	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-5222	Methocarbamol	Methocarbamol	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5222	Methocarbamol	Methocarbamol	NuCare Pharmaceuticals,Inc.	ANDA	Current
68151-2775	Methocarbamol	Methocarbamol	Carilion Materials Management	ANDA	Current
69367-255	Methocarbamol	Methocarbamol	Westminster Pharmaceuticals, LLC	ANDA	Current
69367-256	Methocarbamol	Methocarbamol	Westminster Pharmaceuticals, LLC	ANDA	Current
69543-134	Methocarbamol	Methocarbamol	Virtus Pharmaceuticals	ANDA	Current
69543-134	Methocarbamol	Methocarbamol	Virtus Pharmaceuticals	ANDA	Current
69543-135	Methocarbamol	Methocarbamol	Virtus Pharmaceuticals	ANDA	Current
69543-135	Methocarbamol	Methocarbamol	Virtus Pharmaceuticals	ANDA	Current
71205-019	Methocarbamol	Methocarbamol	Proficient Rx LP	ANDA	Current
71205-019	Methocarbamol	Methocarbamol	Proficient Rx LP	ANDA	Current
71335-0719	Methocarbamol	Methocarbamol	Bryant Ranch Prepack	ANDA	Current
71335-0719	Methocarbamol	Methocarbamol	Bryant Ranch Prepack	ANDA	Current