Application 206071

Type: ANDA
Sponsor: NAVINTA LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHOCARBAMOL	METHOCARBAMOL	SOLUTION;IM-IV	1GM/10ML (100MG/ML)	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A206071-001	METHOCARBAMOL	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV			2017-11-24

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 · 41 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
2026-02-19 14:30 UTC	2026-02	A206071-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV		2017-11-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206071-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV		2017-11-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206071-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV		2017-11-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206071-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV		2017-11-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206071-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV		2017-11-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206071-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV		2017-11-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206071-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV		2017-11-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206071-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-11-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206071-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV		2017-11-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206071-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-11-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206071-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-11-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206071-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-11-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206071-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-11-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206071-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-11-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206071-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-11-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206071-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-11-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206071-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-11-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206071-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-11-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206071-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-11-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206071-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-11-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206071-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-11-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206071-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-11-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206071-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-11-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206071-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-11-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206071-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-11-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206071-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-11-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206071-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-11-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206071-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-11-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206071-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-11-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206071-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-11-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206071-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-11-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206071-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-11-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206071-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-11-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206071-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-11-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206071-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-11-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206071-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-11-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206071-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-11-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206071-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-11-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206071-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-11-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206071-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-11-24	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206071-001	AP	1	`5bbf6a4d5a75…`
2024-10-29 15:01 UTC	2024-10	A206071-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206071-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206071-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206071-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206071-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206071-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206071-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206071-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206071-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206071-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206071-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206071-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206071-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206071-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206071-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206071-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206071-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206071-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206071-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206071-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206071-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206071-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206071-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206071-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206071-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206071-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206071-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206071-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206071-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206071-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206071-001	AP	1	`cb3db0bc1861…`

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 9 · 179 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methocarbamol	METHOCARBAMOL	American Health Packaging	d842fe4e-fc46-4d70-9ca3-b47191672f96	2026-07-30	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Medcore LLC	1a6b7327-fd42-4de0-bd0d-2dd478502d52	2026-07-29	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	PD-Rx Pharmaceuticals, Inc.	3d4a2486-863e-4e9f-be3b-67882863e7d4	2026-07-29	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	PD-Rx Pharmaceuticals, Inc.	6b9ed3a4-46d5-462e-ac93-6b959b314d77	2026-07-29	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	PD-Rx Pharmaceuticals, Inc.	adb49cb7-8900-44dc-add0-22e2cd8235ac	2026-07-29	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	PD-Rx Pharmaceuticals, Inc.	0deb5368-ffdc-40fc-a97c-ba89b7a97e50	2026-07-21	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL TABLETS	REMEDYREPACK INC.	52b20439-6bf4-435e-817a-c3b3fc70846a	2026-07-10	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol
Methocarbamol	METHOCARBAMOL TABLETS	REMEDYREPACK INC.	37767123-8b72-4e1f-b00d-ff3305e9923f	2026-07-10	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol
Methocarbamol	METHOCARBAMOL TABLETS	Unit Dose Solutions, Inc.	561ae476-9e1f-038a-e063-6394a90aa5c7	2026-07-08	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol
Methocarbamol	METHOCARBAMOL TABLETS	Granules Pharmaceuticals Inc.	6f0d3966-962d-fa7c-e053-2a91aa0a8e3c	2026-07-07	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol
Methocarbamol	METHOCARBAMOL	St. Mary's Medical Park Pharmacy	56090def-7caf-e916-e063-6294a90a6ac2	2026-07-07	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL TABLETS	Bryant Ranch Prepack	65c460f6-6470-41ff-abb4-d9d54ecc52f7	2026-07-06	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol
Methocarbamol	METHOCARBAMOL	Unit Dose Solutions, Inc.	5539d4f6-1192-2770-e063-6394a90a1e50	2026-06-27	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	A-S Medication Solutions	9617e2b0-4255-4542-95ca-9ee1818ca450	2026-06-26	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	HAWAII REPACK, INC.	8643032a-c491-4ae4-ac46-5e0c4c79dc5b	2026-06-26	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL TABLETS	St. Mary's Medical Park Pharmacy	7d4dd78a-f902-6ff2-e053-2991aa0ac7d7	2026-06-26	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol
Methocarbamol	METHOCARBAMOL	A-S Medication Solutions	cfdc0d68-00ad-44d6-b932-819cc3d5d60e	2026-06-26	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	A-S Medication Solutions	b81a8e64-ae41-409b-94a6-b36cb50bc25d	2026-06-26	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	HAWAII REPACK, INC.	c4744824-4c74-411d-aa8e-c63ee9d89913	2026-06-25	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL TABLETS	Preferred Pharmaceuticals Inc.	43f83b87-e169-46fe-98bd-6af373595bd3	2026-06-23	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol

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
68475-002	Methocarbamol	Methocarbamol	Navinta LLC	ANDA	Current
68475-002	Methocarbamol	Methocarbamol	Navinta LLC	ANDA	Current
68475-002	Methocarbamol	Methocarbamol	Navinta LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
50512	ORIG	2017-11-27