Application 204476

Type: ANDA
Sponsor: BAYSHORE PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PRIMAQUINE PHOSPHATE	PRIMAQUINE PHOSPHATE	TABLET;ORAL	EQ 15MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A204476-001	PRIMAQUINE PHOSPHATE	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB		2014-02-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204476-001	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 2 · 41 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	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204476-001	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	AB	2014-02-25	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A204476-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204476-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204476-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204476-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204476-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204476-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204476-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204476-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204476-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204476-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204476-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204476-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204476-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204476-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204476-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204476-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204476-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204476-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204476-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204476-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204476-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204476-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204476-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204476-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204476-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204476-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204476-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204476-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204476-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204476-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204476-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204476-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204476-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204476-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204476-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204476-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204476-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204476-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204476-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204476-001	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Primaquine Phosphate	PRIMAQUINE PHOSPHATE	PD-Rx Pharmaceuticals, Inc.	3f16166d-678e-51aa-e054-00144ff88e88	2026-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204476 application number: ANDA204476 ndc (product): 43063-721
Primaquine Phosphate	PRIMAQUINE PHOSPHATE	Unichem Pharmaceuticals (USA), Inc.	0c8c2bc6-428b-40b6-8114-6df80290878d	2026-02-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204476 application number: ANDA204476 ndc (product): 76385-102

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0440-8187	Primaquine Phosphate	Primaquine Phosphate	Liberty Pharmaceuticals, Inc.	ANDA	Current
0440-8187	Primaquine Phosphate	Primaquine Phosphate	Liberty Pharmaceuticals, Inc.	ANDA	Current
33261-671	Primaquine Phosphate	Primaquine Phosphate	Aidarex Pharmaceuticals LLC	ANDA	Current
43063-721	Primaquine Phosphate	Primaquine Phosphate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-721	Primaquine Phosphate	Primaquine Phosphate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-721	Primaquine Phosphate	Primaquine Phosphate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-721	Primaquine Phosphate	Primaquine Phosphate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-721	Primaquine Phosphate	Primaquine Phosphate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-721	Primaquine Phosphate	Primaquine Phosphate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
60429-035	Primaquine Phosphate	Primaquine Phosphate	Golden State Medical Supply Inc.	ANDA	Current
60429-035	Primaquine Phosphate	Primaquine Phosphate	Golden State Medical Supply	ANDA	Current
76385-102	Primaquine Phosphate	Primaquine Phosphate	Bayshore Pharmaceuticals, LLC	ANDA	Current
76385-102	Primaquine Phosphate	Primaquine Phosphate	Bayshore Pharmaceuticals, LLC	ANDA	Current