Application 091114

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FAMCICLOVIR	FAMCICLOVIR	TABLET;ORAL	125MG	No	No
002	FAMCICLOVIR	FAMCICLOVIR	TABLET;ORAL	250MG	No	No
003	FAMCICLOVIR	FAMCICLOVIR	TABLET;ORAL	500MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A091114-001	FAMCICLOVIR	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2011-03-21
A091114-002	FAMCICLOVIR	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2011-03-21
A091114-003	FAMCICLOVIR	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2011-03-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A091114-001	AB
A091114-002	AB
A091114-003	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 · 126 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	A091114-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2011-03-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091114-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2011-03-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091114-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2011-03-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091114-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2011-03-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091114-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2011-03-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091114-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2011-03-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091114-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2011-03-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091114-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2011-03-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091114-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2011-03-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091114-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2011-03-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091114-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2011-03-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091114-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2011-03-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091114-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2011-03-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091114-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2011-03-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091114-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2011-03-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091114-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2011-03-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091114-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2011-03-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091114-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2011-03-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091114-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2011-03-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091114-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2011-03-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091114-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2011-03-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091114-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2011-03-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091114-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2011-03-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091114-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2011-03-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091114-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2011-03-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091114-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2011-03-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091114-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2011-03-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091114-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2011-03-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091114-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2011-03-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091114-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2011-03-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091114-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2011-03-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091114-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2011-03-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091114-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2011-03-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091114-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2011-03-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091114-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2011-03-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091114-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2011-03-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091114-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2011-03-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091114-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2011-03-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091114-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2011-03-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091114-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2011-03-21	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A091114-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091114-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091114-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091114-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091114-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091114-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091114-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091114-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091114-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091114-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091114-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091114-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091114-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091114-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091114-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091114-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091114-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091114-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091114-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091114-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091114-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091114-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091114-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091114-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091114-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091114-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091114-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091114-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091114-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091114-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091114-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091114-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091114-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091114-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091114-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091114-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091114-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091114-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091114-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091114-001	AB	1	`1e350fbaab3a…`

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
Famciclovir	FAMCICLOVIR	Aurobindo Pharma Limited	fcf0b0fa-bb2c-4f2c-aa9f-1f2da65d8343	2024-06-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091114 application number: ANDA091114 ndc (product): 65862-466 ndc (product): 65862-467 ndc (product): 65862-465
Famciclovir	FAMCICLOVIR	Rising Pharma Holdings, Inc.	d5c46506-a350-44a1-9440-d939da895f16	2024-06-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091114 application number: ANDA091114 ndc (product): 64980-350 ndc (product): 64980-349 ndc (product): 64980-351

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
57237-194	Famciclovir	Famciclovir	Citron Pharma LLC	ANDA	Current
57237-195	Famciclovir	Famciclovir	Citron Pharma LLC	ANDA	Current
57237-196	Famciclovir	Famciclovir	Citron Pharma LLC	ANDA	Current
64980-349	Famciclovir	Famciclovir	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-349	Famciclovir	Famciclovir	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-350	Famciclovir	Famciclovir	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-350	Famciclovir	Famciclovir	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-351	Famciclovir	Famciclovir	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-351	Famciclovir	Famciclovir	Rising Pharmaceuticals, Inc.	ANDA	Current
65862-465	Famciclovir	Famciclovir	Aurobindo Pharma Limited	ANDA	Current
65862-465	Famciclovir	Famciclovir	Aurobindo Pharma Limited	ANDA	Current
65862-465	Famciclovir	Famciclovir	Aurobindo Pharma Limited	ANDA	Current
65862-465	Famciclovir	Famciclovir	Aurobindo Pharma Limited	ANDA	Current
65862-466	Famciclovir	Famciclovir	Aurobindo Pharma Limited	ANDA	Current
65862-466	Famciclovir	Famciclovir	Aurobindo Pharma Limited	ANDA	Current
65862-466	Famciclovir	Famciclovir	Aurobindo Pharma Limited	ANDA	Current
65862-466	Famciclovir	Famciclovir	Aurobindo Pharma Limited	ANDA	Current
65862-467	Famciclovir	Famciclovir	Aurobindo Pharma Limited	ANDA	Current
65862-467	Famciclovir	Famciclovir	Aurobindo Pharma Limited	ANDA	Current
65862-467	Famciclovir	Famciclovir	Aurobindo Pharma Limited	ANDA	Current
65862-467	Famciclovir	Famciclovir	Aurobindo Pharma Limited	ANDA	Current