Application 201570

Type: ANDA
Sponsor: APOTEX INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ABACAVIR SULFATE	ABACAVIR SULFATE	TABLET;ORAL	EQ 300MG BASE	No	No

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

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
A201570-001	ABACAVIR SULFATE	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL			2012-12-17

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 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A201570-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	2012-12-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201570-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	2012-12-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201570-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	2012-12-17	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A201570-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	2012-12-17	`a50c72e98297…`

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	A201570-001	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A201570-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201570-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201570-001	AB	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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Abacavir Sulfate	ABACAVIR SULFATE	Safecor Health, LLC	f7633480-25aa-4326-bec9-82835b486a20	2026-03-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Abacavir Sulfate generic name: ABACAVIR SULFATE
Abacavir Sulfate	ABACAVIR SULFATE	Mylan Institutional Inc.	80c1702a-973c-436a-90f8-69b29674dca0	2025-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Abacavir Sulfate generic name: ABACAVIR SULFATE
Abacavir	ABACAVIR SULFATE	Rising Pharma Holdings, Inc.	ec9e2c36-b9b7-4ac2-a366-f3ad51237f28	2025-04-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ABACAVIR SULFATE
Abacavir	ABACAVIR SULFATE	Aurobindo Pharma Limited	e2214976-657c-4018-b059-1ad66a7e2b6f	2024-05-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ABACAVIR SULFATE
ZIAGEN	ABACAVIR SULFATE	ViiV Healthcare Company	ca73b519-015a-436d-aa3c-af53492825a1	2023-09-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ABACAVIR SULFATE
Abacavir Sulfate	ABACAVIR SULFATE	Mylan Pharmaceuticals Inc.	5676d391-f9a4-44be-9604-954b3d8d0e2b	2021-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Abacavir Sulfate generic name: ABACAVIR SULFATE

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6523	Abacavir Sulfate	Abacavir Sulfate	Major Pharmaceuticals	ANDA	Current
0904-6523	Abacavir Sulfate	Abacavir Sulfate	Major Pharmaceuticals	ANDA	Current
60505-3583	Abacavir Sulfate	Abacavir Sulfate	Apotex Corp	ANDA	Current
60505-3583	Abacavir Sulfate	Abacavir Sulfate	Apotex Corp	ANDA	Current
70518-0640	Abacavir Sulfate	Abacavir Sulfate	REMEDYREPACK INC.	ANDA	Current
70518-0640	Abacavir Sulfate	Abacavir Sulfate	REMEDYREPACK INC.	ANDA	Current