Application 091055

Type: ANDA
Sponsor: STRIDES ARCOLAB LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	TABLET; ORAL	200MG; 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
A091055-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB		2021-01-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091055-001	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
2026-08-18 06:07:40	2026-07	A091055-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-01-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091055-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-01-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091055-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-01-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091055-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-01-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091055-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-01-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091055-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-01-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091055-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-01-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091055-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-01-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091055-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-01-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091055-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-01-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091055-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-01-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091055-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-01-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091055-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-01-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091055-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-01-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091055-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-01-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091055-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-01-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091055-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-01-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091055-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-01-13	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A091055-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-01-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091055-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-01-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091055-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-01-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091055-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-01-13	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091055-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-01-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091055-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-01-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091055-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-01-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091055-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-01-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091055-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-01-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091055-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-01-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091055-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-01-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091055-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-01-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091055-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-01-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091055-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-01-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091055-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-01-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091055-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-01-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091055-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-01-13	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A091055-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-01-13	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A091055-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091055-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091055-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091055-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091055-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091055-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091055-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091055-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091055-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091055-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091055-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091055-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091055-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091055-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091055-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091055-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091055-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091055-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A091055-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091055-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091055-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091055-001	AB	1	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091055-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091055-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091055-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091055-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091055-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091055-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091055-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091055-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091055-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091055-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091055-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091055-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091055-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A091055-001	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Emtricitabine and Tenofovir Disoproxil Fumarate	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	Strides Pharma Science Limited	bc37cba9-83c8-4660-a527-cd77fae9ea87	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091055 application number: ANDA091055 ndc (product): 64380-719
Emtricitabine and Tenofovir Disoproxil Fumarate	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	Golden State Medical Supply, Inc.	bdd87563-251a-d990-e053-2a95a90ad578	2024-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091055 application number: ANDA091055 ndc (product): 51407-112
Emtricitabine and Tenofovir Disoproxil Fumarate	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	Strides Pharma Inc.	7ecc604c-c4b4-4419-a733-ecb11662fc81	2024-03-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091055 application number: ANDA091055 ndc (product): 42543-719

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42543-719	Emtricitabine and Tenofovir Disoproxil Fumarate	EMTRICITABINE and TENOFOVIR Disoproxil Fumarate	Strides Pharma Inc.	ANDA	Current
51407-112	Emtricitabine and Tenofovir Disoproxil Fumarate	EMTRICITABINE and TENOFOVIR Disoproxil Fumarate	Golden State Medical Supply, Inc.	ANDA	Current
51407-112	Emtricitabine and Tenofovir Disoproxil Fumarate	EMTRICITABINE and TENOFOVIR Disoproxil Fumarate	Golden State Medical Supply, Inc.	ANDA	Current
51407-112	Emtricitabine and Tenofovir Disoproxil Fumarate	EMTRICITABINE and TENOFOVIR Disoproxil Fumarate	Golden State Medical Supply, Inc.	ANDA	Current
51407-112	Emtricitabine and Tenofovir Disoproxil Fumarate	EMTRICITABINE and TENOFOVIR Disoproxil Fumarate	Golden State Medical Supply, Inc.	ANDA	Current
64380-719	Emtricitabine and Tenofovir Disoproxil Fumarate	EMTRICITABINE and TENOFOVIR Disoproxil Fumarate	Strides Pharma Science Limited	ANDA	Current
64380-719	Emtricitabine and Tenofovir Disoproxil Fumarate	EMTRICITABINE and TENOFOVIR Disoproxil Fumarate	Strides Pharma Science Limited	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9315	ORIG	2013-08-05