Application 077220

Type: ANDA
Sponsor: LANNETT CO INC

Application Products#

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

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
A077220-001	PILOCARPINE HYDROCHLORIDE	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2005-10-14
A077220-002	PILOCARPINE HYDROCHLORIDE	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2009-05-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077220-001	AB
A077220-002	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077220-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2005-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077220-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2009-05-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077220-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2005-10-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077220-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2009-05-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077220-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2005-10-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077220-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2009-05-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077220-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2005-10-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077220-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2009-05-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077220-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2005-10-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077220-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2009-05-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077220-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2005-10-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077220-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2009-05-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077220-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2005-10-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077220-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2009-05-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077220-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2005-10-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077220-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2009-05-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077220-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2005-10-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077220-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2009-05-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077220-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2005-10-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077220-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2009-05-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077220-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2005-10-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077220-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2009-05-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077220-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2005-10-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077220-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2009-05-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077220-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2005-10-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077220-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2009-05-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077220-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2005-10-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077220-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2009-05-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077220-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2005-10-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077220-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2009-05-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077220-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2005-10-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077220-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2009-05-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077220-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2005-10-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077220-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2009-05-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077220-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2005-10-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077220-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2009-05-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077220-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2005-10-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077220-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2009-05-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077220-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2005-10-14	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077220-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2009-05-06	`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	A077220-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077220-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077220-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077220-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077220-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077220-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077220-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077220-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077220-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077220-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077220-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077220-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077220-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077220-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077220-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077220-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077220-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077220-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077220-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077220-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077220-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077220-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077220-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077220-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077220-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077220-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077220-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077220-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077220-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077220-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077220-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077220-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077220-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077220-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077220-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077220-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077220-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077220-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077220-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077220-002	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pilocarpine Hydrochloride	PILOCARPINE HYDROCHLORIDE	AvPAK	b85547d8-fcec-323d-e053-2995a90a4e7e	2026-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077220 application number: ANDA077220 ndc (product): 50268-652
Pilocarpine Hydrochloride	PILOCARPINE HYDROCHLORIDE	Bryant Ranch Prepack	06c054af-62b4-4373-813a-9bb2e5c92316	2024-12-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077220 application number: ANDA077220
Pilocarpine Hydrochloride	PILOCARPINE HYDROCHLORIDE	Bryant Ranch Prepack	fb97323d-acec-4e4a-af16-efef66d969dc	2024-12-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077220 application number: ANDA077220 ndc (product): 63629-8351
Pilocarpine Hydrochloride	PILOCARPINE HYDROCHLORIDE	Lannett Company, Inc.	8db0db4f-55ad-46b2-af50-e71b4a763aaa	2024-10-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077220 application number: ANDA077220 ndc (product): 0527-1313 ndc (product): 0527-1407
Pilocarpine Hydrochloride	PILOCARPINE HYDROCHLORIDE	Bryant Ranch Prepack	6a73a702-c5e2-44ea-81c8-ee7e60852c41	2024-03-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077220 application number: ANDA077220 ndc (product): 63629-2099

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0527-1313	Pilocarpine Hydrochloride	Pilocarpine Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-1313	Pilocarpine Hydrochloride	Pilocarpine Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-1313	Pilocarpine Hydrochloride	Pilocarpine Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-1313	Pilocarpine Hydrochloride	Pilocarpine Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-1407	Pilocarpine Hydrochloride	Pilocarpine Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-1407	Pilocarpine Hydrochloride	Pilocarpine Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-1407	Pilocarpine Hydrochloride	Pilocarpine Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-1407	Pilocarpine Hydrochloride	Pilocarpine Hydrochloride	Lannett Company, Inc.	ANDA	Current
10135-589	Pilocarpine Hydrochloride	Pilocarpine Hydrochloride	Marlex Pharmaceuticals Inc	ANDA	Current
10135-590	Pilocarpine Hydrochloride	Pilocarpine Hydrochloride	Marlex Pharmaceuticals Inc	ANDA	Current
50268-652	Pilocarpine Hydrochloride	Pilocarpine Hydrochloride	AvPAK	ANDA	Current
50268-652	Pilocarpine Hydrochloride	Pilocarpine Hydrochloride	AvPAK	ANDA	Current
50268-652	Pilocarpine Hydrochloride	Pilocarpine Hydrochloride	AvPAK	ANDA	Current
63629-2099	Pilocarpine Hydrochloride	Pilocarpine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2099	Pilocarpine Hydrochloride	Pilocarpine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8351	Pilocarpine Hydrochloride	Pilocarpine Hydrochloride	Bryant Ranch Prepack	ANDA	Current