Application 204398

Type: ANDA
Sponsor: AKORN INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PILOCARPINE HYDROCHLORIDE	PILOCARPINE HYDROCHLORIDE	SOLUTION;OPHTHALMIC	1%	No	No
002	PILOCARPINE HYDROCHLORIDE	PILOCARPINE HYDROCHLORIDE	SOLUTION;OPHTHALMIC	2%	No	No
003	PILOCARPINE HYDROCHLORIDE	PILOCARPINE HYDROCHLORIDE	SOLUTION;OPHTHALMIC	4%	No	No

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	Approval date
A204398-001	PILOCARPINE HYDROCHLORIDE	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	AT	2017-09-27
A204398-002	PILOCARPINE HYDROCHLORIDE	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION/DROPS / OPHTHALMIC	AT	2017-09-27
A204398-003	PILOCARPINE HYDROCHLORIDE	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION/DROPS / OPHTHALMIC	AT	2017-09-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204398-001	AT
A204398-002	AT
A204398-003	AT

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 4 · 123 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	A204398-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	AT	2017-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204398-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION/DROPS / OPHTHALMIC	AT	2017-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204398-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION/DROPS / OPHTHALMIC	AT	2017-09-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204398-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	AT	2017-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204398-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION/DROPS / OPHTHALMIC	AT	2017-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204398-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION/DROPS / OPHTHALMIC	AT	2017-09-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204398-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2017-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204398-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION / OPHTHALMIC	AT	2017-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204398-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION / OPHTHALMIC	AT	2017-09-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204398-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2017-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204398-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION / OPHTHALMIC	AT	2017-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204398-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION / OPHTHALMIC	AT	2017-09-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204398-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2017-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204398-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION / OPHTHALMIC	AT	2017-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204398-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION / OPHTHALMIC	AT	2017-09-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204398-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2017-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204398-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION / OPHTHALMIC	AT	2017-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204398-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION / OPHTHALMIC	AT	2017-09-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204398-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2017-09-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204398-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION / OPHTHALMIC	AT	2017-09-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204398-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION / OPHTHALMIC	AT	2017-09-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204398-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2017-09-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204398-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION / OPHTHALMIC	AT	2017-09-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204398-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION / OPHTHALMIC	AT	2017-09-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204398-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2017-09-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204398-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION / OPHTHALMIC	AT	2017-09-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204398-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION / OPHTHALMIC	AT	2017-09-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204398-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2017-09-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204398-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION / OPHTHALMIC	AT	2017-09-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204398-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION / OPHTHALMIC	AT	2017-09-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204398-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2017-09-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204398-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION / OPHTHALMIC	AT	2017-09-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204398-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION / OPHTHALMIC	AT	2017-09-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204398-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2017-09-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204398-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION / OPHTHALMIC	AT	2017-09-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204398-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION / OPHTHALMIC	AT	2017-09-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204398-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2017-09-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204398-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION / OPHTHALMIC	AT	2017-09-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204398-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION / OPHTHALMIC	AT	2017-09-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204398-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2017-09-27	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A204398-001	AT	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204398-002	AT	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204398-003	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204398-001	AT	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204398-002	AT	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204398-003	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204398-001	AT	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204398-002	AT	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204398-003	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204398-001	AT	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204398-002	AT	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204398-003	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204398-001	AT	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204398-002	AT	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204398-003	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204398-001	AT	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204398-002	AT	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204398-003	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204398-001	AT	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204398-002	AT	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204398-003	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204398-001	AT	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204398-002	AT	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204398-003	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204398-001	AT	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204398-002	AT	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204398-003	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204398-001	AT	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204398-002	AT	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204398-003	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204398-001	AT	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204398-002	AT	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204398-003	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204398-001	AT	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204398-002	AT	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204398-003	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204398-001	AT	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204398-002	AT	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204398-003	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204398-001	AT	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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pilocarpine Hydrochloride	PILOCARPINE HYDROCHLORIDE	Amneal Pharmaceuticals NY LLC	6272ccac-b543-404d-9938-8583bb59ed2c	2026-04-15	Warnings, Adverse reactions	Name fallback brand name: Pilocarpine Hydrochloride generic name: PILOCARPINE HYDROCHLORIDE
Pilocarpine hydrochloride	PILOCARPINE HYDROCHLORIDE	American Health Packaging	6f950741-fd3f-4bf7-83b0-f5aa9dbceb76	2026-01-23	Warnings, Adverse reactions	Name fallback brand name: Pilocarpine hydrochloride generic name: PILOCARPINE HYDROCHLORIDE
Pilocarpine Hydrochloride	PILOCARPINE HYDROCHLORIDE	AvPAK	b85547d8-fcec-323d-e053-2995a90a4e7e	2026-01-09	Warnings, Adverse reactions	Name fallback brand name: Pilocarpine Hydrochloride generic name: PILOCARPINE HYDROCHLORIDE
Pilocarpine Hydrochloride	PILOCARPINE HYDROCHLORIDE OPHTHALMIC SOLUTION	Somerset Therapeutics, LLC	84428e9a-f486-44d9-ad93-4ea9069a6787	2025-12-22	Warnings, Adverse reactions	Name fallback brand name: Pilocarpine Hydrochloride
Pilocarpine Hydrochloride	PILOCARPINE HYDROCHLORIDE	Aurobindo Pharma Limited	438cfaa3-b5f6-4d75-ac22-b0b4e07bb118	2025-10-03	Warnings, Adverse reactions	Name fallback brand name: Pilocarpine Hydrochloride generic name: PILOCARPINE HYDROCHLORIDE
Pilocarpine Hydrochloride Ophthalmic	PILOCARPINE HYDROCHLORIDE	Amneal Pharmaceuticals NY LLC	93e37b61-7b90-4740-b0b4-17d39d3b03f6	2025-06-02	Warnings, Adverse reactions	Name fallback generic name: PILOCARPINE HYDROCHLORIDE
Qlosi	PILOCARPINE HYDROCHLORIDE	Orasis Pharmaceuticals, Inc.	4ee2a840-1203-473a-aa42-316a3ddf2fbe	2025-05-30	Warnings, Adverse reactions	Name fallback generic name: PILOCARPINE HYDROCHLORIDE
Pilocarpine Hydrochloride	PILOCARPINE HYDROCHLORIDE	Bryant Ranch Prepack	06c054af-62b4-4373-813a-9bb2e5c92316	2024-12-12	Warnings, Adverse reactions	Name fallback brand name: Pilocarpine Hydrochloride generic name: PILOCARPINE HYDROCHLORIDE
Pilocarpine Hydrochloride	PILOCARPINE HYDROCHLORIDE	Bryant Ranch Prepack	fb97323d-acec-4e4a-af16-efef66d969dc	2024-12-06	Warnings, Adverse reactions	Name fallback brand name: Pilocarpine Hydrochloride generic name: PILOCARPINE HYDROCHLORIDE
Salagen	PILOCARPINE HYDROCHLORIDE	Advanz Pharma (US) Corp.	62eda83d-d043-4c7e-8fcf-75d05efbf35b	2024-12-05	Warnings, Adverse reactions	Name fallback generic name: PILOCARPINE HYDROCHLORIDE
Pilocarpine Hydrochloride	PILOCARPINE HYDROCHLORIDE	Lannett Company, Inc.	8db0db4f-55ad-46b2-af50-e71b4a763aaa	2024-10-18	Warnings, Adverse reactions	Name fallback brand name: Pilocarpine Hydrochloride generic name: PILOCARPINE HYDROCHLORIDE
Pilocarpine Hydrochloride	PILOCARPINE HYDROCHLORIDE	Bryant Ranch Prepack	6a73a702-c5e2-44ea-81c8-ee7e60852c41	2024-03-22	Warnings, Adverse reactions	Name fallback brand name: Pilocarpine Hydrochloride generic name: PILOCARPINE HYDROCHLORIDE
VUITY	PILOCARPINE HYDROCHLORIDE	AbbVie Inc.	8d806897-8a2a-4518-8c68-0ec3b778de50	2023-03-28	Warnings, Adverse reactions	Name fallback generic name: PILOCARPINE HYDROCHLORIDE
Pilocarpine Hydrochloride	PILOCARPINE HYDROCHLORIDE	AMICI PHARMACEUTICALS LLC	a86a7b63-5f6a-4c10-9270-24c7b7d50437	2022-06-12	Warnings, Adverse reactions	Name fallback brand name: Pilocarpine Hydrochloride generic name: PILOCARPINE HYDROCHLORIDE
Pilocarpine hydrochloride	PILOCARPINE HYDROCHLORIDE	Actavis Pharma, Inc.	610022b7-7dc9-405a-a580-104657f43bdf	2021-08-31	Warnings, Adverse reactions	Name fallback brand name: Pilocarpine hydrochloride generic name: PILOCARPINE HYDROCHLORIDE
Pilocarpine Hydrochloride	PILOCARPINE HYDROCHLORIDE	Amneal Pharmaceuticals NY LLC	1e87a81a-7084-4436-918b-a50451534307	2021-01-03	Warnings, Adverse reactions	Name fallback brand name: Pilocarpine Hydrochloride generic name: PILOCARPINE HYDROCHLORIDE
Pilocarpine Hydrochloride	PILOCARPINE HYDROCHLORIDE	Sandoz Inc	53fa0b7a-f982-48a7-92c4-6f098683c1ed	2020-05-19	Warnings, Adverse reactions	Name fallback brand name: Pilocarpine Hydrochloride generic name: PILOCARPINE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17478-223	Pilocarpine Hydrochloride	Pilocarpine Hydrochloride	Akorn	ANDA	Current
17478-223	Pilocarpine Hydrochloride	Pilocarpine Hydrochloride	Akorn, Inc.	ANDA	Current
17478-223	Pilocarpine Hydrochloride	Pilocarpine Hydrochloride	Akorn, Inc.	ANDA	Current
17478-223	Pilocarpine Hydrochloride	Pilocarpine Hydrochloride	Akorn	ANDA	Current
17478-224	Pilocarpine Hydrochloride	Pilocarpine Hydrochloride	Akorn	ANDA	Current
17478-224	Pilocarpine Hydrochloride	Pilocarpine Hydrochloride	Akorn, Inc.	ANDA	Current
17478-224	Pilocarpine Hydrochloride	Pilocarpine Hydrochloride	Akorn, Inc.	ANDA	Current
17478-224	Pilocarpine Hydrochloride	Pilocarpine Hydrochloride	Akorn	ANDA	Current
17478-226	Pilocarpine Hydrochloride	Pilocarpine Hydrochloride	Akorn	ANDA	Current
17478-226	Pilocarpine Hydrochloride	Pilocarpine Hydrochloride	Akorn, Inc.	ANDA	Current
17478-226	Pilocarpine Hydrochloride	Pilocarpine Hydrochloride	Akorn, Inc.	ANDA	Current
17478-226	Pilocarpine Hydrochloride	Pilocarpine Hydrochloride	Akorn	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
49892	ORIG	2017-09-29