Application 202438

Type: ANDA
Sponsor: HETERO LABS LTD V

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
A202438-001	FAMCICLOVIR	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2014-09-10
A202438-002	FAMCICLOVIR	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2014-09-10
A202438-003	FAMCICLOVIR	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2014-09-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202438-001	AB
A202438-002	AB
A202438-003	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	A202438-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2014-09-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202438-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2014-09-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202438-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2014-09-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202438-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2014-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202438-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2014-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202438-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2014-09-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202438-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2014-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202438-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2014-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202438-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2014-09-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202438-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2014-09-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202438-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2014-09-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202438-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2014-09-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202438-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2014-09-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202438-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2014-09-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202438-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2014-09-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202438-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2014-09-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202438-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2014-09-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202438-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2014-09-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202438-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2014-09-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202438-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2014-09-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202438-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2014-09-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202438-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2014-09-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202438-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2014-09-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202438-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2014-09-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202438-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2014-09-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202438-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2014-09-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202438-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2014-09-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202438-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2014-09-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202438-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2014-09-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202438-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2014-09-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202438-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2014-09-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202438-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2014-09-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202438-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2014-09-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202438-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2014-09-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202438-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2014-09-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202438-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2014-09-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202438-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2014-09-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202438-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2014-09-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202438-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2014-09-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202438-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2014-09-10	`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	A202438-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202438-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202438-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202438-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202438-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202438-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202438-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202438-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202438-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202438-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202438-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202438-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202438-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202438-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202438-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202438-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202438-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202438-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202438-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202438-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202438-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202438-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202438-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202438-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202438-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202438-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202438-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202438-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202438-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202438-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202438-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202438-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202438-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202438-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202438-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202438-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202438-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202438-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202438-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202438-001	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Famciclovir	FAMCICLOVIR	AvKARE	5723f50e-b0fa-65f0-e063-6294a90a350f	2026-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202438 application number: ANDA202438
Famciclovir	FAMCICLOVIR	Bryant Ranch Prepack	2c579bc7-8130-4935-a999-62b4b1c20706	2025-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202438 application number: ANDA202438 ndc (product): 63629-7890
Famciclovir	FAMCICLOVIR	Camber Pharmaceuticals, Inc.	08c58224-5920-4853-8c59-ec5fbb66c2f6	2025-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202438 application number: ANDA202438 ndc (product): 31722-708 ndc (product): 31722-707 ndc (product): 31722-706
Famciclovir	FAMCICLOVIR	Proficient Rx LP	29b7ea8b-b976-45cb-9006-a27ba797b0fd	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202438 application number: ANDA202438 ndc (product): 63187-998

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17856-0705	Famciclovir	Famciclovir	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
17856-0706	Famciclovir	Famciclovir	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
17856-0708	Famciclovir	Famciclovir	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
31722-706	Famciclovir	Famciclovir	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-706	Famciclovir	Famciclovir	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-707	Famciclovir	Famciclovir	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-707	Famciclovir	Famciclovir	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-708	Famciclovir	Famciclovir	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-708	Famciclovir	Famciclovir	Camber Pharmaceuticals, Inc.	ANDA	Current
50090-3337	Famciclovir	Famciclovir	A-S Medication Solutions	ANDA	Current
63187-998	Famciclovir	Famciclovir	Proficient Rx LP	ANDA	Current
63187-998	Famciclovir	Famciclovir	Proficient Rx LP	ANDA	Current
63187-998	Famciclovir	Famciclovir	Proficient Rx LP	ANDA	Current
63629-7890	Famciclovir	Famciclovir	Bryant Ranch Prepack	ANDA	Current
63629-7890	Famciclovir	Famciclovir	Bryant Ranch Prepack	ANDA	Current