Application 212689

Type: ANDA
Sponsor: ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	TABLET;ORAL	200MG;300MG	No	No
002	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	TABLET;ORAL	100MG;150MG	No	No
003	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	TABLET;ORAL	133MG;200MG	No	No
004	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	TABLET;ORAL	167MG;250MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A212689-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2020-02-28
A212689-002	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	100MG;150MG	TABLET / ORAL	AB	2021-07-01
A212689-003	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	133MG;200MG	TABLET / ORAL	AB	2021-07-01
A212689-004	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	167MG;250MG	TABLET / ORAL	AB	2021-07-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A212689-001	AB
A212689-002	AB
A212689-003	AB
A212689-004	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 4 · 144 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
2026-09-14 22:38:34	2026-08	A212689-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2020-02-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212689-002	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	100MG;150MG	TABLET / ORAL	AB	2021-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212689-003	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	133MG;200MG	TABLET / ORAL	AB	2021-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212689-004	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	167MG;250MG	TABLET / ORAL	AB	2021-07-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212689-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2020-02-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212689-002	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	100MG;150MG	TABLET / ORAL	AB	2021-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212689-003	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	133MG;200MG	TABLET / ORAL	AB	2021-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212689-004	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	167MG;250MG	TABLET / ORAL	AB	2021-07-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212689-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2020-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212689-002	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	100MG;150MG	TABLET / ORAL	AB	2021-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212689-003	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	133MG;200MG	TABLET / ORAL	AB	2021-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212689-004	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	167MG;250MG	TABLET / ORAL	AB	2021-07-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212689-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2020-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212689-002	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	100MG;150MG	TABLET / ORAL	AB	2021-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212689-003	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	133MG;200MG	TABLET / ORAL	AB	2021-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212689-004	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	167MG;250MG	TABLET / ORAL	AB	2021-07-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212689-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2020-02-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212689-002	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	100MG;150MG	TABLET / ORAL	AB	2021-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212689-003	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	133MG;200MG	TABLET / ORAL	AB	2021-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212689-004	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	167MG;250MG	TABLET / ORAL	AB	2021-07-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212689-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2020-02-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212689-002	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	100MG;150MG	TABLET / ORAL	AB	2021-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212689-003	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	133MG;200MG	TABLET / ORAL	AB	2021-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212689-004	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	167MG;250MG	TABLET / ORAL	AB	2021-07-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212689-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2020-02-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212689-002	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	100MG;150MG	TABLET / ORAL	AB	2021-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212689-003	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	133MG;200MG	TABLET / ORAL	AB	2021-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212689-004	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	167MG;250MG	TABLET / ORAL	AB	2021-07-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212689-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2020-02-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212689-002	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	100MG;150MG	TABLET / ORAL	AB	2021-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212689-003	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	133MG;200MG	TABLET / ORAL	AB	2021-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212689-004	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	167MG;250MG	TABLET / ORAL	AB	2021-07-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212689-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2020-02-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212689-002	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	100MG;150MG	TABLET / ORAL	AB	2021-07-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212689-003	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	133MG;200MG	TABLET / ORAL	AB	2021-07-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212689-004	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	167MG;250MG	TABLET / ORAL	AB	2021-07-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212689-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2020-02-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212689-002	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	100MG;150MG	TABLET / ORAL	AB	2021-07-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212689-003	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	133MG;200MG	TABLET / ORAL	AB	2021-07-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212689-004	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	167MG;250MG	TABLET / ORAL	AB	2021-07-01	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 144 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A212689-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212689-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212689-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212689-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212689-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212689-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212689-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212689-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212689-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212689-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212689-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212689-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212689-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212689-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212689-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212689-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212689-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212689-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212689-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212689-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212689-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212689-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212689-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212689-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212689-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212689-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212689-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212689-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212689-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212689-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212689-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212689-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212689-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212689-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212689-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212689-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212689-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212689-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212689-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212689-004	AB	1	`5bbf6a4d5a75…`

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 · 2 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	Zydus Lifesciences Limited	a0ee89b6-72c3-4b99-8d1c-d7473f1d5ef3	2024-11-28		Exact identifier application applno (ANDA): 212689 application number: ANDA212689 ndc (product): 70771-1620 ndc (product): 70771-1709 ndc (product): 70771-1622 ndc (product): 70771-1621
Emtricitabine and tenofovir disoproxil fumarate	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	Zydus Pharmaceuticals USA Inc.	7def7a95-e69e-4985-974a-efacadcecc95	2024-05-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212689 application number: ANDA212689 ndc (product): 70710-1366 ndc (product): 70710-1365 ndc (product): 70710-1367 ndc (product): 70710-1364

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70710-1364	Emtricitabine and tenofovir disoproxil fumarate	Emtricitabine and tenofovir disoproxil fumarate	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70710-1364	Emtricitabine and tenofovir disoproxil fumarate	Emtricitabine and tenofovir disoproxil fumarate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1365	Emtricitabine and tenofovir disoproxil fumarate	Emtricitabine and tenofovir disoproxil fumarate	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70710-1365	Emtricitabine and tenofovir disoproxil fumarate	Emtricitabine and tenofovir disoproxil fumarate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1366	Emtricitabine and tenofovir disoproxil fumarate	Emtricitabine and tenofovir disoproxil fumarate	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70710-1366	Emtricitabine and tenofovir disoproxil fumarate	Emtricitabine and tenofovir disoproxil fumarate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1367	Emtricitabine and tenofovir disoproxil fumarate	Emtricitabine and tenofovir disoproxil fumarate	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70710-1367	Emtricitabine and Tenofovir Disoproxil Fumarate	Emtricitabine and Tenofovir Disoproxil Fumarate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1367	Emtricitabine and tenofovir disoproxil fumarate	Emtricitabine and tenofovir disoproxil fumarate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1594	Emtricitabine and tenofovir disoproxil fumarate	Emtricitabine and tenofovir disoproxil fumarate	Cadila Healthcare Limited	ANDA	Current
70771-1620	Emtricitabine and tenofovir disoproxil fumarate	Emtricitabine and tenofovir disoproxil fumarate	Cadila Healthcare Limited	ANDA	Current
70771-1620	Emtricitabine and tenofovir disoproxil fumarate	Emtricitabine and tenofovir disoproxil fumarate	Zydus Lifesciences Limited	ANDA	Current
70771-1621	Emtricitabine and tenofovir disoproxil fumarate	Emtricitabine and tenofovir disoproxil fumarate	Cadila Healthcare Limited	ANDA	Current
70771-1621	Emtricitabine and tenofovir disoproxil fumarate	Emtricitabine and tenofovir disoproxil fumarate	Zydus Lifesciences Limited	ANDA	Current
70771-1622	Emtricitabine and tenofovir disoproxil fumarate	Emtricitabine and tenofovir disoproxil fumarate	Cadila Healthcare Limited	ANDA	Current
70771-1622	Emtricitabine and tenofovir disoproxil fumarate	Emtricitabine and tenofovir disoproxil fumarate	Zydus Lifesciences Limited	ANDA	Current
70771-1709	Emtricitabine and tenofovir disoproxil fumarate	Emtricitabine and tenofovir disoproxil fumarate	Cadila Healthcare Limited	ANDA	Current
70771-1709	Emtricitabine and tenofovir disoproxil fumarate	Emtricitabine and tenofovir disoproxil fumarate	Zydus Lifesciences Limited	ANDA	Current
72189-227	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	DIRECT RX	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
62248	ORIG	2020-03-23