Application 090958

Type: ANDA
Sponsor: CIPLA 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
A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL			2021-04-02

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	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL		2021-04-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL		2021-04-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL		2021-04-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL		2021-04-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL		2021-04-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL		2021-04-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL		2021-04-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL		2021-04-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL		2021-04-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL		2021-04-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL		2021-04-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL		2021-04-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL		2021-04-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL		2021-04-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL		2021-04-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-04-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-04-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-04-02	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-04-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-04-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-04-02	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL		2021-04-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL		2021-04-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL		2021-04-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL		2021-04-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL		2021-04-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-04-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-04-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-04-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-04-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-04-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-04-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-04-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2021-04-02	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090958-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL		2021-04-02	`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	A090958-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090958-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090958-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A090958-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090958-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090958-001	AB	1	`87673890dc5c…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090958-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090958-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090958-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090958-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090958-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090958-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090958-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090958-001	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 · 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	Cipla USA Inc.	d08c9455-e788-435c-9076-2bdb1a4f5b37	2024-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090958 application number: ANDA090958 ndc (product): 69097-741
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	Exelan Pharmaceuticals, Inc.	31af598d-6ef2-469b-ac4c-3ac805e6fa44	2021-04-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090958 application number: ANDA090958 ndc (product): 76282-677
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	Cipla USA Inc.	1ac2a796-495e-4182-8eec-40363d8a85c0	2021-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090958 application number: ANDA090958 ndc (product): 69097-209

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69097-209	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	Cipla USA Inc.	ANDA	Current
69097-741	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	Cipla USA Inc.	ANDA	Current
76282-677	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	Exelan Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31507	ORIG	2014-02-27