Application 210384

Type: ANDA
Sponsor: SOMERSET THERAPS LLC

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
A210384-001	PILOCARPINE HYDROCHLORIDE	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-11-25
A210384-002	PILOCARPINE HYDROCHLORIDE	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-11-25
A210384-003	PILOCARPINE HYDROCHLORIDE	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-11-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210384-001	AT
A210384-002	AT
A210384-003	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 3 · 114 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	A210384-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210384-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210384-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-11-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210384-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210384-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210384-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-11-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210384-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210384-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210384-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210384-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210384-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210384-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210384-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210384-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210384-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210384-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210384-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210384-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210384-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210384-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210384-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210384-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210384-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210384-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210384-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210384-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210384-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210384-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210384-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210384-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210384-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210384-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210384-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210384-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210384-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210384-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210384-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210384-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210384-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210384-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 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	A210384-001	AT	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210384-002	AT	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210384-003	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210384-001	AT	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210384-002	AT	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210384-003	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210384-001	AT	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210384-002	AT	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210384-003	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210384-001	AT	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210384-002	AT	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210384-003	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210384-001	AT	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210384-002	AT	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210384-003	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210384-001	AT	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210384-002	AT	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210384-003	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210384-001	AT	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210384-002	AT	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210384-003	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210384-001	AT	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210384-002	AT	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210384-003	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210384-001	AT	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210384-002	AT	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210384-003	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210384-001	AT	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210384-002	AT	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210384-003	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210384-001	AT	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210384-002	AT	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210384-003	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210384-001	AT	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210384-002	AT	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210384-003	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210384-001	AT	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210384-002	AT	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210384-003	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210384-001	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pilocarpine Hydrochloride	PILOCARPINE HYDROCHLORIDE OPHTHALMIC SOLUTION	Somerset Therapeutics, LLC	84428e9a-f486-44d9-ad93-4ea9069a6787	2025-12-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210384 application number: ANDA210384 ndc (product): 70069-181 ndc (product): 70069-191 ndc (product): 70069-201

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70069-181	Pilocarpine Hydrochloride	Pilocarpine Hydrochloride Ophthalmic Solution	Somerset Therapeutics, LLC	ANDA	Current
70069-181	Pilocarpine Hydrochloride	Pilocarpine Hydrochloride Ophthalmic Solution	Somerset Therapeutics, LLC	ANDA	Current
70069-181	Pilocarpine Hydrochloride	Pilocarpine Hydrochloride Ophthalmic Solution	Somerset Therapeutics, LLC	ANDA	Current
70069-191	Pilocarpine Hydrochloride	Pilocarpine Hydrochloride Ophthalmic Solution	Somerset Therapeutics, LLC	ANDA	Current
70069-191	Pilocarpine Hydrochloride	Pilocarpine Hydrochloride Ophthalmic Solution	Somerset Therapeutics, LLC	ANDA	Current
70069-191	Pilocarpine Hydrochloride	Pilocarpine Hydrochloride Ophthalmic Solution	Somerset Therapeutics, LLC	ANDA	Current
70069-201	Pilocarpine Hydrochloride	Pilocarpine Hydrochloride Ophthalmic Solution	Somerset Therapeutics, LLC	ANDA	Current
70069-201	Pilocarpine Hydrochloride	Pilocarpine Hydrochloride Ophthalmic Solution	Somerset Therapeutics, LLC	ANDA	Current
70069-201	Pilocarpine Hydrochloride	Pilocarpine Hydrochloride Ophthalmic Solution	Somerset Therapeutics, LLC	ANDA	Current