Application 016084

Type: NDA
Sponsor: CASPER PHARMA LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZYLOPRIM	ALLOPURINOL	TABLET;ORAL	100MG	Yes	No
002	ZYLOPRIM	ALLOPURINOL	TABLET;ORAL	300MG	Yes	Yes
003	ZYLOPRIM	ALLOPURINOL	TABLET;ORAL	200MG	Yes	No

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

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	RLD / RS	Approval date
N016084-001	ZYLOPRIM	ALLOPURINOL	100MG	TABLET / ORAL	AB	RLD, Approved before 1982
N016084-002	ZYLOPRIM	ALLOPURINOL	300MG	TABLET / ORAL	AB	RLD, Approved before 1982
N016084-003	ZYLOPRIM	ALLOPURINOL	200MG	TABLET / ORAL	AB	RLD	2022-08-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N016084-001	AB
N016084-002	AB
N016084-003	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 · 112 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N016084-001	ZYLOPRIM	100MG	TABLET / ORAL	AB	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016084-002	ZYLOPRIM	300MG	TABLET / ORAL	AB	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016084-003	ZYLOPRIM	200MG	TABLET / ORAL	AB	RLD	2022-08-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016084-001	ZYLOPRIM	100MG	TABLET / ORAL	AB	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016084-002	ZYLOPRIM	300MG	TABLET / ORAL	AB	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016084-003	ZYLOPRIM	200MG	TABLET / ORAL	AB	RLD	2022-08-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016084-001	ZYLOPRIM	100MG	TABLET / ORAL	AB	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016084-002	ZYLOPRIM	300MG	TABLET / ORAL	AB	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016084-003	ZYLOPRIM	200MG	TABLET / ORAL	AB	RLD	2022-08-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016084-001	ZYLOPRIM	100MG	TABLET / ORAL	AB	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016084-002	ZYLOPRIM	300MG	TABLET / ORAL	AB	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016084-003	ZYLOPRIM	200MG	TABLET / ORAL	AB	RLD	2022-08-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016084-001	ZYLOPRIM	100MG	TABLET / ORAL	AB	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016084-002	ZYLOPRIM	300MG	TABLET / ORAL	AB	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016084-003	ZYLOPRIM	200MG	TABLET / ORAL	AB	RLD	2022-08-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016084-001	ZYLOPRIM	100MG	TABLET / ORAL	AB	RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016084-002	ZYLOPRIM	300MG	TABLET / ORAL	AB	RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016084-003	ZYLOPRIM	200MG	TABLET / ORAL	AB	RLD	2022-08-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016084-001	ZYLOPRIM	100MG	TABLET / ORAL	AB	RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016084-002	ZYLOPRIM	300MG	TABLET / ORAL	AB	RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016084-003	ZYLOPRIM	200MG	TABLET / ORAL	AB	RLD	2022-08-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016084-001	ZYLOPRIM	100MG	TABLET / ORAL	AB	RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016084-002	ZYLOPRIM	300MG	TABLET / ORAL	AB	RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016084-003	ZYLOPRIM	200MG	TABLET / ORAL	AB	RLD	2022-08-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016084-001	ZYLOPRIM	100MG	TABLET / ORAL	AB	RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016084-002	ZYLOPRIM	300MG	TABLET / ORAL	AB	RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016084-003	ZYLOPRIM	200MG	TABLET / ORAL	AB	RLD	2022-08-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016084-001	ZYLOPRIM	100MG	TABLET / ORAL	AB	RLD, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016084-002	ZYLOPRIM	300MG	TABLET / ORAL	AB	RLD, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016084-003	ZYLOPRIM	200MG	TABLET / ORAL	AB	RLD	2022-08-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016084-001	ZYLOPRIM	100MG	TABLET / ORAL	AB	RLD, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N016084-002	ZYLOPRIM	300MG	TABLET / ORAL	AB	RLD, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N016084-003	ZYLOPRIM	200MG	TABLET / ORAL	AB	RLD	2022-08-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016084-001	ZYLOPRIM	100MG	TABLET / ORAL	AB	RLD, Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016084-002	ZYLOPRIM	300MG	TABLET / ORAL	AB	RLD, Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016084-003	ZYLOPRIM	200MG	TABLET / ORAL	AB	RLD	2022-08-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016084-001	ZYLOPRIM	100MG	TABLET / ORAL	AB	RLD, Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016084-002	ZYLOPRIM	300MG	TABLET / ORAL	AB	RLD, Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016084-003	ZYLOPRIM	200MG	TABLET / ORAL	AB	RLD	2022-08-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016084-001	ZYLOPRIM	100MG	TABLET / ORAL	AB	RLD, Approved before 1982		`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 98 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N016084-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016084-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016084-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016084-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016084-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016084-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016084-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016084-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016084-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016084-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016084-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016084-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016084-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016084-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016084-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016084-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016084-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016084-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016084-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016084-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016084-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016084-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016084-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016084-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016084-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016084-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016084-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016084-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016084-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016084-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016084-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N016084-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N016084-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016084-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016084-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016084-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016084-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016084-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016084-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016084-001	AB	1	`1e350fbaab3a…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allopurinol	ALLOPURINOL	Rising Pharma Holdings, Inc.	30ad5ba2-1cef-4933-b104-0597f6a2aaa2	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016084 application number: NDA016084 ndc (product): 16571-885 ndc (product): 16571-883 ndc (product): 16571-884
Allopurinol	ALLOPURINOL	Coupler LLC	2d6ce57f-a9df-319e-e063-6394a90ac93f	2025-02-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016084 application number: NDA016084

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16571-883	Allopurinol	allopurinol	Rising Pharma Holdings, Inc.	NDA AUTHORIZED GENERIC	Current
16571-884	Allopurinol	allopurinol	Rising Pharma Holdings, Inc.	NDA AUTHORIZED GENERIC	Current
16571-885	Allopurinol	allopurinol	Rising Pharma Holdings, Inc.	NDA AUTHORIZED GENERIC	Current
65483-991	ZYLOPRIM	allopurinol	Prometheus Laboratories Inc.	NDA	Current
65483-993	ZYLOPRIM	allopurinol	Prometheus Laboratories Inc.	NDA	Current
70199-015	Zyloprim	allopurinol	Casper Pharma LLC	NDA	Current
70199-016	Zyloprim	allopurinol	Casper Pharma LLC	NDA	Current
70199-031	Zyloprim	allopurinol	Casper Pharma LLC	NDA	Current
70199-031	Zyloprim	allopurinol	Casper Pharma LLC	NDA	Current
70199-032	Zyloprim	allopurinol	Casper Pharma LLC	NDA	Current
70199-032	Zyloprim	allopurinol	Casper Pharma LLC	NDA	Current
70199-033	Zyloprim	allopurinol	Casper Pharma LLC	NDA	Current
70199-033	Zyloprim	allopurinol	Casper Pharma LLC	NDA	Current
70518-0551	ZYLOPRIM	allopurinol	REMEDYREPACK INC.	NDA	Current
70518-0551	ZYLOPRIM	allopurinol	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83885	SUPPL	2025-10-23
83884	SUPPL	2025-10-23
75541	SUPPL	2023-09-22
75540	SUPPL	2023-09-22
75539	SUPPL	2023-09-22
75538	SUPPL	2023-09-22
75537	SUPPL	2023-09-22
72101	SUPPL	2022-09-19
71799	SUPPL	2022-08-15
56650	SUPPL	2018-12-07
56622	SUPPL	2018-12-04
20049	SUPPL	2007-07-09
415	SUPPL	2002-07-17