Application 020622

Type: NDA
Sponsor: TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	COPAXONE	GLATIRAMER ACETATE	FOR SOLUTION;SUBCUTANEOUS	20MG/VIAL	No	No
002	COPAXONE	GLATIRAMER ACETATE	INJECTABLE;SUBCUTANEOUS	20MG/ML	Yes	Yes
003	COPAXONE	GLATIRAMER ACETATE	INJECTABLE;SUBCUTANEOUS	40MG/ML	Yes	Yes

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

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
N020622-001	COPAXONE	GLATIRAMER ACETATE	20MG/VIAL	FOR SOLUTION / SUBCUTANEOUS		RLD	1996-12-20
N020622-002	COPAXONE	GLATIRAMER ACETATE	20MG/ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2002-02-12
N020622-003	COPAXONE	GLATIRAMER ACETATE	40MG/ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2014-01-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N020622-002	AP
N020622-003	AP

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 4 · 132 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
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020622-002	COPAXONE	20MG/ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2002-02-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020622-003	COPAXONE	40MG/ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2014-01-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020622-001	COPAXONE	20MG/VIAL	FOR SOLUTION / SUBCUTANEOUS		RLD	1996-12-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020622-002	COPAXONE	20MG/ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2002-02-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020622-003	COPAXONE	40MG/ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2014-01-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020622-001	COPAXONE	20MG/VIAL	FOR SOLUTION / SUBCUTANEOUS		RLD	1996-12-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020622-002	COPAXONE	20MG/ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2002-02-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020622-003	COPAXONE	40MG/ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2014-01-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020622-001	COPAXONE	20MG/VIAL	FOR SOLUTION / SUBCUTANEOUS		RLD	1996-12-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020622-002	COPAXONE	20MG/ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2002-02-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020622-003	COPAXONE	40MG/ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2014-01-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020622-001	COPAXONE	20MG/VIAL	FOR SOLUTION / SUBCUTANEOUS			1996-12-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020622-002	COPAXONE	20MG/ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2002-02-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020622-003	COPAXONE	40MG/ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2014-01-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020622-001	COPAXONE	20MG/VIAL	FOR SOLUTION / SUBCUTANEOUS			1996-12-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020622-002	COPAXONE	20MG/ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2002-02-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020622-003	COPAXONE	40MG/ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2014-01-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020622-001	COPAXONE	20MG/VIAL	FOR SOLUTION / SUBCUTANEOUS			1996-12-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020622-002	COPAXONE	20MG/ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2002-02-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020622-003	COPAXONE	40MG/ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2014-01-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020622-001	COPAXONE	20MG/VIAL	FOR SOLUTION / SUBCUTANEOUS			1996-12-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020622-002	COPAXONE	20MG/ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2002-02-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020622-003	COPAXONE	40MG/ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2014-01-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020622-001	COPAXONE	20MG/VIAL	FOR SOLUTION / SUBCUTANEOUS			1996-12-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020622-002	COPAXONE	20MG/ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2002-02-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020622-003	COPAXONE	40MG/ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2014-01-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020622-001	COPAXONE	20MG/VIAL	FOR SOLUTION / SUBCUTANEOUS			1996-12-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020622-002	COPAXONE	20MG/ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2002-02-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020622-003	COPAXONE	40MG/ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2014-01-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020622-001	COPAXONE	20MG/VIAL	FOR SOLUTION / SUBCUTANEOUS			1996-12-20	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020622-002	COPAXONE	20MG/ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2002-02-12	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020622-003	COPAXONE	40MG/ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2014-01-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020622-001	COPAXONE	20MG/VIAL	FOR SOLUTION / SUBCUTANEOUS			1996-12-20	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020622-002	COPAXONE	20MG/ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2002-02-12	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020622-003	COPAXONE	40MG/ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2014-01-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020622-001	COPAXONE	20MG/VIAL	FOR SOLUTION / SUBCUTANEOUS			1996-12-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020622-002	COPAXONE	20MG/ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2002-02-12	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020622-003	COPAXONE	40MG/ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2014-01-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020622-001	COPAXONE	20MG/VIAL	FOR SOLUTION / SUBCUTANEOUS			1996-12-20	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020622-002	COPAXONE	20MG/ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2002-02-12	`c0c555d07b60…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N020622-002	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020622-003	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N020622-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020622-003	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020622-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020622-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020622-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020622-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020622-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020622-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020622-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020622-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020622-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020622-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020622-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020622-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020622-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020622-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020622-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020622-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020622-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020622-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020622-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020622-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020622-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020622-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020622-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020622-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020622-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020622-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020622-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020622-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020622-002	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020622-003	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020622-002	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020622-003	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020622-002	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020622-003	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020622-002	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020622-003	AP	1	`4b0b4de00fa7…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020622-003	8232250	2030-08-19	U-441	2014-02-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020622-003	8399413	2030-08-19	U-441	2014-02-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020622-003	8969302	2030-08-19	U-441	2015-03-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020622-003	9155776	2030-08-19	U-441	2015-10-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020622-003	9402874	2030-08-19	U-441	2016-08-02	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N020622-003	8232250	2030-08-19	U-441	2014-02-26	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020622-003	8399413	2030-08-19	U-441	2014-02-26	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020622-003	8969302	2030-08-19	U-441	2015-03-03	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020622-003	9155776	2030-08-19	U-441	2015-10-13	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020622-003	9402874	2030-08-19	U-441	2016-08-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020622-003	8232250	2030-08-19	U-441	2014-02-26	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020622-003	8399413	2030-08-19	U-441	2014-02-26	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020622-003	8969302	2030-08-19	U-441	2015-03-03	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020622-003	9155776	2030-08-19	U-441	2015-10-13	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020622-003	9402874	2030-08-19	U-441	2016-08-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020622-003	8232250	2030-08-19	U-441	2014-02-26	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020622-003	8399413	2030-08-19	U-441	2014-02-26	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020622-003	8969302	2030-08-19	U-441	2015-03-03	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020622-003	9155776	2030-08-19	U-441	2015-10-13	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020622-003	9402874	2030-08-19	U-441	2016-08-02	`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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Copaxone	GLATIRAMER ACETATE	Teva Neuroscience, Inc.	aa88f583-4f5f-433b-80b4-1f4c9fb28357	2026-06-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020622 application number: NDA020622 ndc (product): 68546-325 ndc (product): 68546-317

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 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68546-317	Copaxone	Glatiramer Acetate	Teva Neuroscience, Inc.	NDA	Current
68546-317	Copaxone	Glatiramer Acetate	Teva Neuroscience, Inc.	NDA	Current
68546-317	Copaxone	Glatiramer Acetate	Teva Neuroscience, Inc.	NDA	Current
68546-317	Copaxone	Glatiramer Acetate	Teva Neuroscience, Inc.	NDA	Current
68546-317	Copaxone	Glatiramer Acetate	Teva Neuroscience, Inc.	NDA	Current
68546-317	Copaxone	Glatiramer Acetate	Teva Neuroscience, Inc.	NDA	Current
68546-317	Copaxone	Glatiramer Acetate	Teva Neuroscience, Inc.	NDA	Current
68546-317	Copaxone	Glatiramer Acetate	Teva Neuroscience, Inc.	NDA	Current
68546-317	Copaxone	Glatiramer Acetate	Teva Neuroscience, Inc.	NDA	Current
68546-317	Copaxone	Glatiramer Acetate	Teva Neuroscience, Inc.	NDA	Current
68546-317	Copaxone	Glatiramer Acetate	Teva Neuroscience, Inc.	NDA	Current
68546-325	Copaxone	Glatiramer Acetate	Teva Neuroscience, Inc.	NDA	Current
68546-325	Copaxone	Glatiramer Acetate	Teva Neuroscience, Inc.	NDA	Current
68546-325	Copaxone	Glatiramer Acetate	Teva Neuroscience, Inc.	NDA	Current
68546-325	Copaxone	Glatiramer Acetate	Teva Neuroscience, Inc.	NDA	Current
68546-325	Copaxone	Glatiramer Acetate	Teva Neuroscience, Inc.	NDA	Current
68546-325	Copaxone	Glatiramer Acetate	Teva Neuroscience, Inc.	NDA	Current
68546-325	Copaxone	Glatiramer Acetate	Teva Neuroscience, Inc.	NDA	Current
68546-325	Copaxone	Glatiramer Acetate	Teva Neuroscience, Inc.	NDA	Current
68546-325	Copaxone	Glatiramer Acetate	Teva Neuroscience, Inc.	NDA	Current
68546-325	Copaxone	Glatiramer Acetate	Teva Neuroscience, Inc.	NDA	Current
68546-325	Copaxone	Glatiramer Acetate	Teva Neuroscience, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82808	SUPPL	2025-07-11
82801	SUPPL	2025-07-11
82800	SUPPL	2025-07-11
81141	SUPPL	2025-02-07
81139	SUPPL	2025-02-07
80929	SUPPL	2025-02-05
80928	SUPPL	2025-02-05
80927	SUPPL	2025-02-05
76614	SUPPL	2023-11-17
76608	SUPPL	2023-11-17
73108	SUPPL	2023-01-06
73093	SUPPL	2023-01-05
70782	SUPPL	2022-04-18
70779	SUPPL	2022-04-18
70035	SUPPL	2022-02-01
70005	SUPPL	2022-01-31
64086	SUPPL	2020-07-24
64043	SUPPL	2020-07-23
63027	SUPPL	2020-05-15
61494	SUPPL	2020-01-02
61471	SUPPL	2019-12-30
59393	SUPPL	2019-07-22
59391	SUPPL	2019-07-22
57676	ORIG	2019-02-15
55439	SUPPL	2018-09-12
55418	SUPPL	2018-09-10
51899	SUPPL	2018-01-26
51846	SUPPL	2018-01-26
45785	SUPPL	2016-11-02
12856	SUPPL	2014-01-31
2891	SUPPL	2014-01-29
34966	SUPPL	2013-03-12
12855	SUPPL	2009-03-17
25331	SUPPL	2009-03-03
41485	SUPPL	2007-04-09
34965	SUPPL	2003-04-28
2890	SUPPL	2002-08-29
2889	SUPPL	2002-02-12