Application 202912

Type: ANDA
Sponsor: LUPIN LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE	ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE	TABLET;ORAL	EQ 300MG BASE;150MG;300MG	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
A202912-001	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE	ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE	EQ 300MG BASE;150MG;300MG	TABLET / ORAL			2013-12-05

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	Product TE source text	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A202912-001	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE	EQ 300MG BASE;150MG;300MG	TABLET / ORAL	AB	2013-12-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202912-001	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE	EQ 300MG BASE;150MG;300MG	TABLET / ORAL	AB	2013-12-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202912-001	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE	EQ 300MG BASE;150MG;300MG	TABLET / ORAL	AB	2013-12-05	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202912-001	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE	EQ 300MG BASE;150MG;300MG	TABLET / ORAL		2013-12-05	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202912-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202912-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202912-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202912-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202912-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202912-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202912-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202912-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202912-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202912-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202912-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202912-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202912-001	AB	1	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	A202912-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202912-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202912-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202912-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202912-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202912-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202912-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202912-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202912-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202912-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202912-001	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ABACAVIR, LAMIVUDINE AND ZIDOVUDINE	ABACAVIR , LAMIVUDINE AND ZIDOVUDINE	Lupin Pharmaceuticals, Inc.	f5f7c0d9-a247-4308-8269-32accc490ea6	2023-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202912 application number: ANDA202912 ndc (product): 68180-286

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
57297-286	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE	LUPIN LIMITED	ANDA	Current
68180-286	ABACAVIR, LAMIVUDINE AND ZIDOVUDINE	ABACAVIR , LAMIVUDINE AND ZIDOVUDINE	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-286	ABACAVIR, LAMIVUDINE AND ZIDOVUDINE	ABACAVIR , LAMIVUDINE AND ZIDOVUDINE	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-286	ABACAVIR, LAMIVUDINE AND ZIDOVUDINE	ABACAVIR , LAMIVUDINE AND ZIDOVUDINE	Lupin Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
32339	ORIG	2013-12-09