Application 020237

Type: NDA
Sponsor: CONCORDIA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SALAGEN	PILOCARPINE HYDROCHLORIDE	TABLET;ORAL	5MG	Yes	No
002	SALAGEN	PILOCARPINE HYDROCHLORIDE	TABLET;ORAL	7.5MG	Yes	Yes

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

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
N020237-001	SALAGEN	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RLD	1994-03-22
N020237-002	SALAGEN	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	RLD, RS	2003-04-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020237-001	AB
N020237-002	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 · 82 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	N020237-001	SALAGEN	5MG	TABLET / ORAL	AB	RLD	1994-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020237-002	SALAGEN	7.5MG	TABLET / ORAL	AB	RLD, RS	2003-04-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020237-001	SALAGEN	5MG	TABLET / ORAL	AB	RLD	1994-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020237-002	SALAGEN	7.5MG	TABLET / ORAL	AB	RLD, RS	2003-04-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020237-001	SALAGEN	5MG	TABLET / ORAL	AB	RLD	1994-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020237-002	SALAGEN	7.5MG	TABLET / ORAL	AB	RLD, RS	2003-04-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020237-001	SALAGEN	5MG	TABLET / ORAL	AB	RLD	1994-03-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020237-002	SALAGEN	7.5MG	TABLET / ORAL	AB	RLD, RS	2003-04-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020237-001	SALAGEN	5MG	TABLET / ORAL	AB	RLD	1994-03-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020237-002	SALAGEN	7.5MG	TABLET / ORAL	AB	RLD, RS	2003-04-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020237-001	SALAGEN	5MG	TABLET / ORAL	AB	RLD	1994-03-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020237-002	SALAGEN	7.5MG	TABLET / ORAL	AB	RLD, RS	2003-04-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020237-001	SALAGEN	5MG	TABLET / ORAL	AB	RLD	1994-03-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020237-002	SALAGEN	7.5MG	TABLET / ORAL	AB	RLD, RS	2003-04-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020237-001	SALAGEN	5MG	TABLET / ORAL	AB	RLD	1994-03-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020237-002	SALAGEN	7.5MG	TABLET / ORAL	AB	RLD, RS	2003-04-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020237-001	SALAGEN	5MG	TABLET / ORAL	AB	RLD	1994-03-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020237-002	SALAGEN	7.5MG	TABLET / ORAL	AB	RLD, RS	2003-04-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020237-001	SALAGEN	5MG	TABLET / ORAL	AB	RLD	1994-03-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020237-002	SALAGEN	7.5MG	TABLET / ORAL	AB	RLD, RS	2003-04-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020237-001	SALAGEN	5MG	TABLET / ORAL	AB	RLD	1994-03-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020237-002	SALAGEN	7.5MG	TABLET / ORAL	AB	RLD, RS	2003-04-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020237-001	SALAGEN	5MG	TABLET / ORAL	AB	RLD	1994-03-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020237-002	SALAGEN	7.5MG	TABLET / ORAL	AB	RLD, RS	2003-04-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020237-001	SALAGEN	5MG	TABLET / ORAL	AB	RLD	1994-03-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020237-002	SALAGEN	7.5MG	TABLET / ORAL	AB	RLD, RS	2003-04-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020237-001	SALAGEN	5MG	TABLET / ORAL	AB	RLD	1994-03-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020237-002	SALAGEN	7.5MG	TABLET / ORAL	AB	RLD, RS	2003-04-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020237-001	SALAGEN	5MG	TABLET / ORAL	AB	RLD	1994-03-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020237-002	SALAGEN	7.5MG	TABLET / ORAL	AB	RLD, RS	2003-04-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020237-001	SALAGEN	5MG	TABLET / ORAL	AB	RLD	1994-03-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020237-002	SALAGEN	7.5MG	TABLET / ORAL	AB	RLD, RS	2003-04-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020237-001	SALAGEN	5MG	TABLET / ORAL	AB	RLD	1994-03-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020237-002	SALAGEN	7.5MG	TABLET / ORAL	AB	RLD, RS	2003-04-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020237-001	SALAGEN	5MG	TABLET / ORAL	AB	RLD	1994-03-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020237-002	SALAGEN	7.5MG	TABLET / ORAL	AB	RLD, RS	2003-04-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020237-001	SALAGEN	5MG	TABLET / ORAL	AB	RLD	1994-03-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020237-002	SALAGEN	7.5MG	TABLET / ORAL	AB	RLD, RS	2003-04-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020237-001	SALAGEN	5MG	TABLET / ORAL	AB	RLD	1994-03-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020237-002	SALAGEN	7.5MG	TABLET / ORAL	AB	RLD, RS	2003-04-18	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	N020237-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020237-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020237-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020237-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020237-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020237-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020237-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020237-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020237-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020237-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020237-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020237-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020237-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020237-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020237-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020237-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020237-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020237-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020237-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020237-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020237-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020237-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020237-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020237-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020237-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020237-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020237-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020237-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020237-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020237-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020237-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020237-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020237-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020237-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020237-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020237-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020237-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020237-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020237-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020237-002	AB	1	`782e0a99824c…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pilocarpine hydrochloride	PILOCARPINE HYDROCHLORIDE	American Health Packaging	6f950741-fd3f-4bf7-83b0-f5aa9dbceb76	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020237 application number: NDA020237 ndc (product): 68084-928
Salagen	PILOCARPINE HYDROCHLORIDE	Advanz Pharma (US) Corp.	62eda83d-d043-4c7e-8fcf-75d05efbf35b	2024-12-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020237 application number: NDA020237 ndc (product): 59212-705 ndc (product): 59212-775
Pilocarpine hydrochloride	PILOCARPINE HYDROCHLORIDE	Actavis Pharma, Inc.	610022b7-7dc9-405a-a580-104657f43bdf	2021-08-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020237 application number: NDA020237 ndc (product): 0228-2837 ndc (product): 0228-2801

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0228-2801	Pilocarpine hydrochloride	Pilocarpine hydrochloride	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-2801	Pilocarpine hydrochloride	Pilocarpine hydrochloride	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-2801	Pilocarpine hydrochloride	Pilocarpine hydrochloride	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-2837	Pilocarpine hydrochloride	Pilocarpine hydrochloride	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-2837	Pilocarpine hydrochloride	Pilocarpine hydrochloride	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-2837	Pilocarpine hydrochloride	Pilocarpine hydrochloride	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
59212-705	Salagen	Pilocarpine Hydrochloride	Concordia Pharmaceuticals Inc.	NDA	Current
59212-705	Salagen	Pilocarpine Hydrochloride	Concordia Pharmaceuticals Inc.	NDA	Current
59212-705	Salagen	Pilocarpine Hydrochloride	Concordia Pharmaceuticals Inc.	NDA	Current
59212-775	Salagen	Pilocarpine Hydrochloride	Concordia Pharmaceuticals Inc.	NDA	Current
59212-775	Salagen	Pilocarpine Hydrochloride	Concordia Pharmaceuticals Inc.	NDA	Current
59212-775	Salagen	Pilocarpine Hydrochloride	Concordia Pharmaceuticals Inc.	NDA	Current
62856-705	Salagen	pilocarpine hyrochloride	Eisai Inc.	NDA	Current
62856-705	Salagen	pilocarpine hyrochloride	Eisai Inc.	NDA	Current
62856-705	Salagen	pilocarpine hyrochloride	Eisai Inc.	NDA	Current
62856-775	Salagen	pilocarpine hyrochloride	Eisai Inc.	NDA	Current
62856-775	Salagen	pilocarpine hyrochloride	Eisai Inc.	NDA	Current
62856-775	Salagen	pilocarpine hyrochloride	Eisai Inc.	NDA	Current
68084-928	Pilocarpine hydrochloride	Pilocarpine hydrochloride	American Health Packaging	NDA AUTHORIZED GENERIC	Current
68084-928	Pilocarpine hydrochloride	Pilocarpine hydrochloride	American Health Packaging	NDA AUTHORIZED GENERIC	Current
68084-928	Pilocarpine hydrochloride	Pilocarpine hydrochloride	American Health Packaging	NDA AUTHORIZED GENERIC	Current
68084-928	Pilocarpine hydrochloride	Pilocarpine hydrochloride	American Health Packaging	NDA AUTHORIZED GENERIC	Current
68151-3015	Pilocarpine hydrochloride	Pilocarpine hydrochloride	Carilion Materials Management	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
20547	SUPPL	2007-07-06
24630	SUPPL	2004-06-07
2221	SUPPL	2004-06-07
24632	SUPPL	2003-05-29
12351	SUPPL	2003-04-28
34410	SUPPL	2002-06-10
24631	SUPPL	2002-06-10
12350	SUPPL	2002-06-10
2223	SUPPL	2002-06-10
20546	SUPPL	1998-02-11
2222	SUPPL	1998-02-11