Application 209921

Type: ANDA
Sponsor: ANI PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PENICILLAMINE	PENICILLAMINE	CAPSULE;ORAL	250MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A209921-001	LUXZYLA	PENICILLAMINE	250MG	CAPSULE / ORAL			2019-05-07

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 2 · 42 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
2026-08-18 06:07:40	2026-07	A209921-001	LUXZYLA	250MG	CAPSULE / ORAL		2019-05-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209921-001	LUXZYLA	250MG	CAPSULE / ORAL		2019-05-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209921-001	LUXZYLA	250MG	CAPSULE / ORAL		2019-05-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209921-001	LUXZYLA	250MG	CAPSULE / ORAL		2019-05-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209921-001	LUXZYLA	250MG	CAPSULE / ORAL		2019-05-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209921-001	LUXZYLA	250MG	CAPSULE / ORAL		2019-05-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209921-001	LUXZYLA	250MG	CAPSULE / ORAL		2019-05-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209921-001	LUXZYLA	250MG	CAPSULE / ORAL		2019-05-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209921-001	LUXZYLA	250MG	CAPSULE / ORAL		2019-05-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209921-001	LUXZYLA	250MG	CAPSULE / ORAL		2019-05-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209921-001	LUXZYLA	250MG	CAPSULE / ORAL		2019-05-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209921-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-05-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209921-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-05-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209921-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-05-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209921-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-05-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209921-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-05-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209921-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-05-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209921-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-05-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209921-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-05-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209921-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-05-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209921-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-05-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209921-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-05-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209921-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-05-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209921-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-05-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209921-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-05-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209921-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-05-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209921-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-05-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209921-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-05-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209921-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-05-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209921-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-05-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209921-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-05-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209921-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-05-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209921-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-05-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209921-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-05-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209921-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-05-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209921-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-05-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209921-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-05-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209921-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-05-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209921-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-05-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209921-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-05-07	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209921-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209921-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209921-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209921-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209921-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209921-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209921-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209921-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209921-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209921-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209921-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209921-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209921-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209921-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209921-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209921-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209921-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209921-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209921-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209921-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209921-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209921-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209921-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209921-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209921-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209921-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209921-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209921-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209921-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209921-001	AB	1	`cb3db0bc1861…`

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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
penicillamine	PENICILLAMINE	Par Health USA, LLC	72ee469c-f9ef-4bb4-922f-5d71276664a5	2026-07-31	Warnings, Adverse reactions	Name fallback brand name: penicillamine generic name: PENICILLAMINE
Penicillamine	PENICILLAMINE	Par Health USA, LLC	01e79d8f-8c74-4f48-b761-9f225fabf93d	2026-07-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Penicillamine generic name: PENICILLAMINE
Cuprimine	PENICILLAMINE	Bausch Health US, LLC	80e736d3-2017-4d68-94b4-38255c3c59c6	2026-01-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PENICILLAMINE
Depen	PENICILLAMINE	Viatris Specialty LLC	38f8ae60-b354-11de-8a39-0800200c9a66	2025-09-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PENICILLAMINE
Penicillamine	PENICILLAMINE	Granules Pharmaceuticals Inc.	f658b20a-269f-4e78-a79b-a56a5ed8dc1b	2025-05-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Penicillamine generic name: PENICILLAMINE
AAGYLUR	PENICILLAMINE	Cycle Pharmaceuticals Ltd.	ddbd84a9-1c39-42e0-a271-138784e1dc58	2024-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PENICILLAMINE
Penicillamine	PENICILLAMINE	Actavis Pharma, Inc.	594d7a82-af1d-41c4-98ee-0ea6895fc237	2024-09-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Penicillamine generic name: PENICILLAMINE
Penicillamine	PENICILLAMINE	Breckenridge Pharmaceutical, Inc.	1320f46b-e243-4e93-b9c9-ad8eb7828de5	2024-02-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Penicillamine generic name: PENICILLAMINE
Penicillamine	PENICILLAMINE	Lupin Pharmaceuticals, Inc.	f6ecaf47-902f-4378-b524-7a88f20ba138	2022-12-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Penicillamine generic name: PENICILLAMINE
Penicillamine	PENICILLAMINE	Navinta LLC	064fb48d-aa34-4e52-9295-10f2ca4c77dc	2022-12-02	Warnings, Adverse reactions	Name fallback brand name: Penicillamine generic name: PENICILLAMINE
Penicillamine	PENICILLAMINE	Proficient Rx LP	c92335c6-f6fa-4768-9401-55c6b7f87699	2022-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Penicillamine generic name: PENICILLAMINE
Penicillamine	PENICILLAMINE	Dr. Reddy's Laboratories Inc.	15d08594-83a9-cc7a-92ef-1bac0427e121	2020-08-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Penicillamine generic name: PENICILLAMINE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43975-309	Penicillamine	Penicillamine	ANI Pharmaceuticals, Inc.	ANDA	Current
43975-309	Penicillamine	Penicillamine	ANI Pharmaceuticals, Inc.	ANDA	Current
43975-309	Penicillamine	Penicillamine	ANI Pharmaceuticals, Inc.	ANDA	Current
43975-309	Penicillamine	Penicillamine	Amerigen Pharmaceuticals, Inc.	ANDA	Current
62559-970	Penicillamine	Penicillamine	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-970	Penicillamine	Penicillamine	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-970	Penicillamine	Penicillamine	ANI Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
59088	ORIG	2019-06-17