Application 203259

Type: ANDA
Sponsor: HETERO LABS LTD V

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LAMIVUDINE AND ZIDOVUDINE	LAMIVUDINE; ZIDOVUDINE	TABLET;ORAL	150MG;300MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A203259-001	LAMIVUDINE AND ZIDOVUDINE	LAMIVUDINE; ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB		2014-02-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203259-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A203259-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	2014-02-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203259-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	2014-02-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203259-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	2014-02-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203259-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	2014-02-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203259-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	2014-02-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203259-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	2014-02-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203259-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	2014-02-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203259-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	2014-02-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203259-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	2014-02-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203259-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	2014-02-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203259-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	2014-02-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203259-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	2014-02-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203259-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	2014-02-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203259-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	2014-02-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203259-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	2014-02-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203259-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	2014-02-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203259-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	2014-02-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203259-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	2014-02-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203259-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	2014-02-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203259-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	2014-02-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203259-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	2014-02-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203259-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	2014-02-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203259-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	2014-02-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203259-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	2014-02-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203259-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	2014-02-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203259-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	2014-02-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203259-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	2014-02-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203259-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	2014-02-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203259-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	2014-02-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203259-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	2014-02-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203259-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	2014-02-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203259-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	2014-02-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203259-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	2014-02-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203259-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	2014-02-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203259-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	2014-02-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203259-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	2014-02-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203259-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	2014-02-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203259-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	2014-02-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203259-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	2014-02-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203259-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	2014-02-03	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A203259-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203259-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203259-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203259-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203259-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203259-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203259-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203259-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203259-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203259-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203259-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203259-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203259-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203259-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203259-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203259-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203259-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203259-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203259-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203259-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203259-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203259-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203259-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203259-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203259-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203259-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203259-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203259-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203259-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203259-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203259-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203259-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203259-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203259-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203259-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203259-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203259-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203259-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203259-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203259-001	AB	1	`e64feba35796…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lamivudine and Zidovudine	LAMIVUDINE AND ZIDOVUDINE	Camber Pharmaceuticals, Inc.	e816e8f5-1e50-4f49-8bea-92da0121d26e	2026-03-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203259 application number: ANDA203259 ndc (product): 31722-739
LAMIVUDINE AND ZIDOVUDINE	LAMIVUDINE AND ZIDOVUDINE	XLCare Pharmaceuticals, Inc	55520835-0f24-4e52-af8c-d65841ccaba7	2023-01-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203259 application number: ANDA203259 ndc (product): 72865-144
Lamivudine and Zidovudine	LAMIVUDINE AND ZIDOVUDINE	Exelan Pharmaceuticals Inc.	4cf565c3-bdec-4c18-93c1-cc7fa8331c90	2019-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203259 application number: ANDA203259 ndc (product): 76282-115

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
31722-739	Lamivudine and Zidovudine	Lamivudine and Zidovudine	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-739	Lamivudine and Zidovudine	Lamivudine and Zidovudine	Camber Pharmaceuticals, Inc.	ANDA	Current
72865-144	LAMIVUDINE AND ZIDOVUDINE	lamivudine and zidovudine	XLCare Pharmaceuticals, Inc	ANDA	Current
76282-115	Lamivudine and Zidovudine	Lamivudine and Zidovudine	Exelan Pharmaceuticals Inc.	ANDA	Current