Application 214193

Type: ANDA
Sponsor: AMNEAL

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
A214193-001	PILOCARPINE HYDROCHLORIDE	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	AT	2020-09-21
A214193-002	PILOCARPINE HYDROCHLORIDE	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION/DROPS / OPHTHALMIC	AT	2020-09-21
A214193-003	PILOCARPINE HYDROCHLORIDE	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION/DROPS / OPHTHALMIC	AT	2020-09-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214193-001	AT
A214193-002	AT
A214193-003	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 · 111 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	A214193-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	AT	2020-09-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214193-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION/DROPS / OPHTHALMIC	AT	2020-09-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214193-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION/DROPS / OPHTHALMIC	AT	2020-09-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214193-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	AT	2020-09-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214193-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION/DROPS / OPHTHALMIC	AT	2020-09-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214193-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION/DROPS / OPHTHALMIC	AT	2020-09-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214193-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214193-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214193-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214193-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214193-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214193-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214193-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214193-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214193-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214193-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214193-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214193-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214193-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214193-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214193-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214193-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214193-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214193-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214193-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214193-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214193-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214193-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214193-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214193-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214193-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214193-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214193-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214193-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214193-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214193-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214193-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214193-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214193-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214193-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 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	A214193-001	AT	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214193-002	AT	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214193-003	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214193-001	AT	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214193-002	AT	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214193-003	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214193-001	AT	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214193-002	AT	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214193-003	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214193-001	AT	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214193-002	AT	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214193-003	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214193-001	AT	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214193-002	AT	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214193-003	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214193-001	AT	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214193-002	AT	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214193-003	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214193-001	AT	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214193-002	AT	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214193-003	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214193-001	AT	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214193-002	AT	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214193-003	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214193-001	AT	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214193-002	AT	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214193-003	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214193-001	AT	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214193-002	AT	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214193-003	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214193-001	AT	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214193-002	AT	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214193-003	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214193-001	AT	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214193-002	AT	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214193-003	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214193-001	AT	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214193-002	AT	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214193-003	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214193-001	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	Amneal Pharmaceuticals NY LLC	1e87a81a-7084-4436-918b-a50451534307	2021-01-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214193 application number: ANDA214193 ndc (product): 69238-1745 ndc (product): 69238-1747 ndc (product): 69238-1746

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
60219-1745	Pilocarpine Hydrochloride	Pilocarpine Hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
60219-1746	Pilocarpine Hydrochloride	Pilocarpine Hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
60219-1747	Pilocarpine Hydrochloride	Pilocarpine Hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1745	Pilocarpine Hydrochloride	Pilocarpine Hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1745	Pilocarpine Hydrochloride	Pilocarpine Hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1746	Pilocarpine Hydrochloride	Pilocarpine Hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1746	Pilocarpine Hydrochloride	Pilocarpine Hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1747	Pilocarpine Hydrochloride	Pilocarpine Hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1747	Pilocarpine Hydrochloride	Pilocarpine Hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current