Application 090636

Type: ANDA
Sponsor: HETERO LABS LTD III

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TENOFOVIR DISOPROXIL FUMARATE	TENOFOVIR DISOPROXIL FUMARATE	TABLET;ORAL	300MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A090636-001	TENOFOVIR DISOPROXIL FUMARATE	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB		2018-01-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090636-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A090636-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-01-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090636-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-01-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090636-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-01-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090636-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-01-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090636-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-01-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090636-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-01-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090636-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-01-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090636-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-01-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090636-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-01-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090636-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-01-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090636-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-01-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090636-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-01-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090636-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-01-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090636-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-01-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090636-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-01-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090636-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-01-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090636-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-01-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090636-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-01-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090636-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-01-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090636-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-01-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090636-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-01-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090636-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-01-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090636-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-01-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090636-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-01-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090636-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-01-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090636-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-01-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090636-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-01-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090636-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-01-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090636-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-01-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090636-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-01-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090636-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-01-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090636-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-01-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090636-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-01-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090636-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-01-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090636-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-01-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090636-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-01-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090636-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-01-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090636-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-01-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090636-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-01-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090636-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-01-26	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090636-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090636-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090636-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090636-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090636-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090636-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090636-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090636-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090636-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090636-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090636-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090636-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090636-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090636-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090636-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090636-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090636-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090636-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090636-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090636-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090636-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090636-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090636-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090636-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090636-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090636-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090636-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090636-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090636-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090636-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090636-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090636-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090636-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090636-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090636-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090636-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090636-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090636-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090636-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090636-001	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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tenofovir Disoproxil Fumarate	TENOFOVIR DISOPROXIL FUMARATE	AvKARE	7f0bc342-0a0a-1d28-e053-2991aa0a28b9	2026-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090636 application number: ANDA090636 ndc (product): 42291-800
Tenofovir Disoproxil Fumarate	TENOFOVIR DISOPROXIL FUMARATE	PD-Rx Pharmaceuticals, Inc.	08a30772-02fc-4f63-e063-6394a90afd43	2025-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090636 application number: ANDA090636
Tenofovir Disoproxil Fumarate	TENOFOVIR DISOPROXIL FUMARATE	A-S Medication Solutions	67e0e1b7-6a45-4d63-b569-00826832c25a	2024-08-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090636 application number: ANDA090636
Tenofovir Disoproxil Fumarate	TENOFOVIR DISOPROXIL FUMARATE	Bryant Ranch Prepack	18285dda-d63f-4f0e-821f-a4f2df335c35	2023-08-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090636 application number: ANDA090636
Tenofovir Disoproxil Fumarate	TENOFOVIR DISOPROXIL FUMARATE	Camber Pharmaceuticals, Inc.	1ac4c628-f01f-42d4-b8e6-d12273aefc6d	2023-01-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090636 application number: ANDA090636 ndc (product): 31722-535
Tenofovir Disoproxil Fumarate	TENOFOVIR DISOPROXIL FUMARATE	NorthStar RxLLC	eaeb1670-4e39-4541-8ff7-47057f3f5c36	2018-12-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090636 application number: ANDA090636 ndc (product): 16714-820

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-820	Tenofovir Disoproxil Fumarate	Tenofovir Disoproxil Fumarate	NorthStar RxLLC	ANDA	Current
31722-535	Tenofovir Disoproxil Fumarate	Tenofovir Disoproxil Fumarate	Camber Pharmaceuticals, Inc.	ANDA	Current
42291-800	Tenofovir Disoproxil Fumarate	Tenofovir Disoproxil Fumarate	AvKARE, Inc.	ANDA	Current
42291-800	Tenofovir Disoproxil Fumarate	Tenofovir Disoproxil Fumarate	AvKARE	ANDA	Current
42291-800	Tenofovir Disoproxil Fumarate	Tenofovir Disoproxil Fumarate	AvKARE	ANDA	Current
70518-2151	Tenofovir Disoproxil Fumarate	Tenofovir Disoproxil Fumarate	REMEDYREPACK INC.	ANDA	Current
70518-2151	Tenofovir Disoproxil Fumarate	Tenofovir Disoproxil Fumarate	REMEDYREPACK INC.	ANDA	Current
70518-2151	Tenofovir Disoproxil Fumarate	Tenofovir Disoproxil Fumarate	REMEDYREPACK INC.	ANDA	Current
70518-2151	Tenofovir Disoproxil Fumarate	Tenofovir Disoproxil Fumarate	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9282	ORIG	2010-04-05