Application 091606

Type: ANDA
Sponsor: APOTEX

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LAMIVUDINE	LAMIVUDINE	TABLET;ORAL	150MG	No	No
002	LAMIVUDINE	LAMIVUDINE	TABLET;ORAL	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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091606-001	LAMIVUDINE	LAMIVUDINE	150MG	TABLET / ORAL	AB		2011-12-02
A091606-002	LAMIVUDINE	LAMIVUDINE	300MG	TABLET / ORAL	AB		2011-12-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A091606-001	AB
A091606-002	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 3 · 84 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	A091606-001	LAMIVUDINE	150MG	TABLET / ORAL	AB	2011-12-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091606-002	LAMIVUDINE	300MG	TABLET / ORAL	AB	2011-12-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091606-001	LAMIVUDINE	150MG	TABLET / ORAL	AB	2011-12-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091606-002	LAMIVUDINE	300MG	TABLET / ORAL	AB	2011-12-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091606-001	LAMIVUDINE	150MG	TABLET / ORAL	AB	2011-12-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091606-002	LAMIVUDINE	300MG	TABLET / ORAL	AB	2011-12-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091606-001	LAMIVUDINE	150MG	TABLET / ORAL	AB	2011-12-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091606-002	LAMIVUDINE	300MG	TABLET / ORAL	AB	2011-12-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091606-001	LAMIVUDINE	150MG	TABLET / ORAL	AB	2011-12-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091606-002	LAMIVUDINE	300MG	TABLET / ORAL	AB	2011-12-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091606-001	LAMIVUDINE	150MG	TABLET / ORAL	AB	2011-12-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091606-002	LAMIVUDINE	300MG	TABLET / ORAL	AB	2011-12-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091606-001	LAMIVUDINE	150MG	TABLET / ORAL	AB	2011-12-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091606-002	LAMIVUDINE	300MG	TABLET / ORAL	AB	2011-12-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091606-001	LAMIVUDINE	150MG	TABLET / ORAL	AB	2011-12-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091606-002	LAMIVUDINE	300MG	TABLET / ORAL	AB	2011-12-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091606-001	LAMIVUDINE	150MG	TABLET / ORAL	AB	2011-12-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091606-002	LAMIVUDINE	300MG	TABLET / ORAL	AB	2011-12-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091606-001	LAMIVUDINE	150MG	TABLET / ORAL	AB	2011-12-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091606-002	LAMIVUDINE	300MG	TABLET / ORAL	AB	2011-12-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091606-001	LAMIVUDINE	150MG	TABLET / ORAL	AB	2011-12-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091606-002	LAMIVUDINE	300MG	TABLET / ORAL	AB	2011-12-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091606-001	LAMIVUDINE	150MG	TABLET / ORAL	AB	2011-12-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091606-002	LAMIVUDINE	300MG	TABLET / ORAL	AB	2011-12-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091606-001	LAMIVUDINE	150MG	TABLET / ORAL	AB	2011-12-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091606-002	LAMIVUDINE	300MG	TABLET / ORAL	AB	2011-12-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091606-001	LAMIVUDINE	150MG	TABLET / ORAL	AB	2011-12-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091606-002	LAMIVUDINE	300MG	TABLET / ORAL	AB	2011-12-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091606-001	LAMIVUDINE	150MG	TABLET / ORAL	AB	2011-12-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091606-002	LAMIVUDINE	300MG	TABLET / ORAL	AB	2011-12-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091606-001	LAMIVUDINE	150MG	TABLET / ORAL	AB	2011-12-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091606-002	LAMIVUDINE	300MG	TABLET / ORAL	AB	2011-12-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091606-001	LAMIVUDINE	150MG	TABLET / ORAL	AB	2011-12-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091606-002	LAMIVUDINE	300MG	TABLET / ORAL	AB	2011-12-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091606-001	LAMIVUDINE	150MG	TABLET / ORAL	AB	2011-12-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091606-002	LAMIVUDINE	300MG	TABLET / ORAL	AB	2011-12-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091606-001	LAMIVUDINE	150MG	TABLET / ORAL	AB	2011-12-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091606-002	LAMIVUDINE	300MG	TABLET / ORAL	AB	2011-12-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091606-001	LAMIVUDINE	150MG	TABLET / ORAL	AB	2011-12-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091606-002	LAMIVUDINE	300MG	TABLET / ORAL	AB	2011-12-02	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A091606-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091606-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091606-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091606-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091606-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091606-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091606-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091606-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091606-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091606-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091606-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091606-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091606-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091606-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091606-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091606-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091606-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091606-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091606-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091606-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091606-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091606-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091606-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091606-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091606-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091606-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091606-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091606-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091606-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091606-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091606-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091606-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091606-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091606-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091606-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091606-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091606-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091606-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091606-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091606-002	AB	1	`bb7c543d1eb4…`

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
LAMIVUDINE	LAMIVUDINE	Major Pharmaceuticals	6fd4d6b9-65ea-4988-8d6f-dd220ec5052d	2026-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091606 application number: ANDA091606 ndc (product): 0904-6583
LAMIVUDINE	LAMIVUDINE	Golden State Medical Supply, Inc.	f3637209-303e-4232-ae79-07315a990973	2025-11-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091606 application number: ANDA091606 ndc (product): 60429-354 ndc (product): 60429-353
LAMIVUDINE	LAMIVUDINE	Apotex Corp.	34c02bcc-d6ff-99d4-8e6a-4a91908adca8	2025-09-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091606 application number: ANDA091606 ndc (product): 60505-3251 ndc (product): 60505-3252
Lamivudine	LAMIVUDINE	American Health Packaging	7ad3a998-8e4d-43a0-8930-8f7a6ae539b4	2024-09-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091606 application number: ANDA091606 ndc (product): 60687-720

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6583	LAMIVUDINE	lamivudine	Major Pharmaceuticals	ANDA	Current
0904-6583	LAMIVUDINE	lamivudine	Major Pharmaceuticals	ANDA	Current
53808-0843	LAMIVUDINE	lamivudine	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0844	LAMIVUDINE	lamivudine	State of Florida DOH Central Pharmacy	ANDA	Current
60429-353	LAMIVUDINE	lamivudine	Golden State Medical Supply, Inc.	ANDA	Current
60429-353	LAMIVUDINE	lamivudine	Golden State Medical Supply, Inc.	ANDA	Current
60429-353	LAMIVUDINE	lamivudine	Golden State Medical Supply, Inc.	ANDA	Current
60429-354	LAMIVUDINE	lamivudine	Golden State Medical Supply, Inc.	ANDA	Current
60429-354	LAMIVUDINE	lamivudine	Golden State Medical Supply, Inc.	ANDA	Current
60429-354	LAMIVUDINE	lamivudine	Golden State Medical Supply, Inc.	ANDA	Current
60505-3251	LAMIVUDINE	lamivudine	Apotex Corp.	ANDA	Current
60505-3251	LAMIVUDINE	lamivudine	Apotex Corp.	ANDA	Current
60505-3251	LAMIVUDINE	lamivudine	Apotex Corp.	ANDA	Current
60505-3252	LAMIVUDINE	lamivudine	Apotex Corp.	ANDA	Current
60505-3252	LAMIVUDINE	lamivudine	Apotex Corp.	ANDA	Current
60505-3252	LAMIVUDINE	lamivudine	Apotex Corp.	ANDA	Current
60687-720	Lamivudine	Lamivudine	American Health Packaging	ANDA	Current