Application 083082

Type: ANDA
Sponsor: HIKMA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CHLOROQUINE PHOSPHATE	CHLOROQUINE PHOSPHATE	TABLET;ORAL	250MG	No	No
002	CHLOROQUINE PHOSPHATE	CHLOROQUINE PHOSPHATE	TABLET;ORAL	500MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A083082-001	CHLOROQUINE PHOSPHATE	CHLOROQUINE PHOSPHATE	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		Approved before 1982
A083082-002	CHLOROQUINE PHOSPHATE	CHLOROQUINE PHOSPHATE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL			1999-09-17

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 2 of 3 · 88 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
2019-12-13 00:20 UTC	2019-12	A083082-001	CHLOROQUINE PHOSPHATE	EQ 150MG BASE	TABLET / ORAL	AA	RS, Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A083082-002	CHLOROQUINE PHOSPHATE	EQ 300MG BASE	TABLET / ORAL	AA		1999-09-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A083082-001	CHLOROQUINE PHOSPHATE	250MG	TABLET / ORAL		Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A083082-002	CHLOROQUINE PHOSPHATE	500MG	TABLET / ORAL			1999-09-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A083082-001	CHLOROQUINE PHOSPHATE	250MG	TABLET / ORAL		Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A083082-002	CHLOROQUINE PHOSPHATE	500MG	TABLET / ORAL			1999-09-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A083082-001	CHLOROQUINE PHOSPHATE	250MG	TABLET / ORAL		Approved before 1982		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A083082-002	CHLOROQUINE PHOSPHATE	500MG	TABLET / ORAL			1999-09-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A083082-001	CHLOROQUINE PHOSPHATE	250MG	TABLET / ORAL		Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A083082-002	CHLOROQUINE PHOSPHATE	500MG	TABLET / ORAL			1999-09-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A083082-001	CHLOROQUINE PHOSPHATE	250MG	TABLET / ORAL		Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A083082-002	CHLOROQUINE PHOSPHATE	500MG	TABLET / ORAL			1999-09-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A083082-001	CHLOROQUINE PHOSPHATE	250MG	TABLET / ORAL		Approved before 1982		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A083082-002	CHLOROQUINE PHOSPHATE	500MG	TABLET / ORAL			1999-09-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A083082-001	CHLOROQUINE PHOSPHATE	EQ 150MG BASE	TABLET / ORAL	AA	RS, Approved before 1982		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A083082-002	CHLOROQUINE PHOSPHATE	EQ 300MG BASE	TABLET / ORAL	AA		1999-09-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A083082-001	CHLOROQUINE PHOSPHATE	EQ 150MG BASE	TABLET / ORAL	AA	RS, Approved before 1982		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A083082-002	CHLOROQUINE PHOSPHATE	EQ 300MG BASE	TABLET / ORAL	AA		1999-09-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A083082-001	CHLOROQUINE PHOSPHATE	EQ 150MG BASE	TABLET / ORAL	AA	RS, Approved before 1982		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A083082-002	CHLOROQUINE PHOSPHATE	EQ 300MG BASE	TABLET / ORAL	AA		1999-09-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A083082-001	CHLOROQUINE PHOSPHATE	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		Approved before 1982		`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A083082-002	CHLOROQUINE PHOSPHATE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL			1999-09-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A083082-001	CHLOROQUINE PHOSPHATE	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		Approved before 1982		`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A083082-002	CHLOROQUINE PHOSPHATE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL			1999-09-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A083082-001	CHLOROQUINE PHOSPHATE	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		Approved before 1982		`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A083082-002	CHLOROQUINE PHOSPHATE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL			1999-09-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A083082-001	CHLOROQUINE PHOSPHATE	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		Approved before 1982		`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A083082-002	CHLOROQUINE PHOSPHATE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL			1999-09-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A083082-001	CHLOROQUINE PHOSPHATE	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		Approved before 1982		`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A083082-002	CHLOROQUINE PHOSPHATE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL			1999-09-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A083082-001	CHLOROQUINE PHOSPHATE	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		Approved before 1982		`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A083082-002	CHLOROQUINE PHOSPHATE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL			1999-09-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A083082-001	CHLOROQUINE PHOSPHATE	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		Approved before 1982		`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A083082-002	CHLOROQUINE PHOSPHATE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL			1999-09-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A083082-001	CHLOROQUINE PHOSPHATE	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		Approved before 1982		`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A083082-002	CHLOROQUINE PHOSPHATE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL			1999-09-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A083082-001	CHLOROQUINE PHOSPHATE	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		Approved before 1982		`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A083082-002	CHLOROQUINE PHOSPHATE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL			1999-09-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A083082-001	CHLOROQUINE PHOSPHATE	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		Approved before 1982		`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A083082-002	CHLOROQUINE PHOSPHATE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL			1999-09-17	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A083082-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A083082-002	AA	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A083082-001	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A083082-002	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A083082-001	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A083082-002	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A083082-001	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A083082-002	AA	1	`ea99ee380514…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Chloroquine Phosphate	CHLOROQUINE PHOSPHATE	Rising Pharma Holdings, Inc.	ee944d28-f596-4163-a502-e779c0d622bc	2026-07-02	Warnings, Adverse reactions	Name fallback brand name: Chloroquine Phosphate generic name: CHLOROQUINE PHOSPHATE
Chloroquine Phosphate	CHLOROQUINE PHOSPHATE	Rising Pharma Holdings, Inc.	06c69e2b-211b-4746-9f3a-f86d36520570	2026-07-02	Warnings, Adverse reactions	Name fallback brand name: Chloroquine Phosphate generic name: CHLOROQUINE PHOSPHATE
Chloroquine Phosphate	CHLOROQUINE PHOSPHATE	AvKARE	0a342f72-45f9-3e12-e063-6394a90ae33e	2026-01-13	Warnings, Adverse reactions	Name fallback brand name: Chloroquine Phosphate generic name: CHLOROQUINE PHOSPHATE
CHLOROQUINE PHOSPHATE	CHLOROQUINE PHOSPHATE	Chartwell RX, LLC	ff199f31-bfda-45f8-adbd-4662f7054f1c	2025-12-10	Warnings, Adverse reactions	Name fallback brand name: CHLOROQUINE PHOSPHATE generic name: CHLOROQUINE PHOSPHATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-1195	Chloroquine	Chloroquine Phosphate	West-ward Pharmaceutical Corp	ANDA	Current
0143-2125	Chloroquine	Chloroquine Phosphate	West-ward Pharmaceutical Corp	ANDA	Current
55289-856	Chloroquine	Chloroquine Phosphate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
68151-0487	Chloroquine	Chloroquine Phosphate	Carilion Materials Management	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
39571	SUPPL	2009-11-16