Application 205412

Type: ANDA
Sponsor: HETERO LABS LTD V

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ABACAVIR SULFATE; LAMIVUDINE	ABACAVIR SULFATE;LAMIVUDINE	TABLET;ORAL	600;300MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A205412-001	ABACAVIR SULFATE AND LAMIVUDINE	ABACAVIR SULFATE; LAMIVUDINE	EQ 600MG BASE;300MG	TABLET / ORAL	AB		2025-04-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205412-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A205412-001	ABACAVIR SULFATE AND LAMIVUDINE	EQ 600MG BASE;300MG	TABLET / ORAL	AB	2025-04-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205412-001	ABACAVIR SULFATE AND LAMIVUDINE	EQ 600MG BASE;300MG	TABLET / ORAL	AB	2025-04-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205412-001	ABACAVIR SULFATE AND LAMIVUDINE	EQ 600MG BASE;300MG	TABLET / ORAL	AB	2025-04-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205412-001	ABACAVIR SULFATE AND LAMIVUDINE	EQ 600MG BASE;300MG	TABLET / ORAL	AB	2025-04-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205412-001	ABACAVIR SULFATE AND LAMIVUDINE	EQ 600MG BASE;300MG	TABLET / ORAL	AB	2025-04-16	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A205412-001	ABACAVIR SULFATE AND LAMIVUDINE	EQ 600MG BASE;300MG	TABLET / ORAL	AB	2025-04-16	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A205412-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205412-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205412-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205412-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205412-001	AB	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A205412-001	AB	1	`a50c72e98297…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ABACAVIR and LAMIVUDINE	ABACAVIR AND LAMIVUDINE	Camber Pharmaceuticals, Inc.	e8988924-c18c-4e91-ab79-2d84e72bfa0d	2025-05-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205412 application number: ANDA205412

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
32668	ORIG	2014-09-29