Application 201022

Type: ANDA
Sponsor: MACLEODS PHARMS 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
A201022-001	FAMCICLOVIR	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2012-01-12
A201022-002	FAMCICLOVIR	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2012-01-12
A201022-003	FAMCICLOVIR	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2012-01-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201022-001	AB
A201022-002	AB
A201022-003	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	A201022-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2012-01-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201022-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2012-01-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201022-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2012-01-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201022-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2012-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201022-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2012-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201022-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2012-01-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201022-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2012-01-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201022-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2012-01-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201022-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2012-01-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201022-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2012-01-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201022-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2012-01-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201022-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2012-01-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201022-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2012-01-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201022-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2012-01-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201022-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2012-01-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201022-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2012-01-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201022-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2012-01-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201022-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2012-01-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201022-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2012-01-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201022-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2012-01-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201022-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2012-01-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201022-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2012-01-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201022-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2012-01-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201022-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2012-01-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201022-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2012-01-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201022-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2012-01-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201022-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2012-01-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201022-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2012-01-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201022-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2012-01-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201022-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2012-01-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201022-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2012-01-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201022-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2012-01-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201022-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2012-01-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201022-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2012-01-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201022-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2012-01-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201022-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2012-01-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201022-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2012-01-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201022-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2012-01-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201022-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2012-01-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201022-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2012-01-12	`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	A201022-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201022-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201022-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201022-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201022-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201022-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201022-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201022-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201022-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201022-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201022-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201022-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201022-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201022-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201022-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201022-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201022-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201022-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201022-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201022-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201022-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201022-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201022-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201022-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201022-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201022-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201022-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201022-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201022-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201022-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201022-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201022-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201022-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201022-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201022-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201022-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201022-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201022-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201022-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201022-001	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Famciclovir	FAMCICLOVIR	Bryant Ranch Prepack	d3faac3a-5c8c-4987-9703-c161fb29ec56	2025-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201022 application number: ANDA201022
Famciclovir	FAMCICLOVIR	Macleods Pharmaceuticals Limited	eeeee9c4-8566-4100-8ca4-3df936a3365d	2025-09-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201022 application number: ANDA201022 ndc (product): 33342-026 ndc (product): 33342-024 ndc (product): 33342-025
Famciclovir	FAMCICLOVIR	Proficient Rx LP	b75abffb-0a90-4abd-8ed8-81be1d8fe364	2023-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201022 application number: ANDA201022 ndc (product): 71205-609

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
33342-024	Famciclovir	Famciclovir	Macleods Pharmaceuticals Limited	ANDA	Current
33342-024	Famciclovir	Famciclovir	Macleods Pharmaceuticals Limited	ANDA	Current
33342-024	Famciclovir	Famciclovir	Macleods Pharmaceuticals Limited	ANDA	Current
33342-024	Famciclovir	Famciclovir	Macleods Pharmaceuticals Limited	ANDA	Current
33342-025	Famciclovir	Famciclovir	Macleods Pharmaceuticals Limited	ANDA	Current
33342-025	Famciclovir	Famciclovir	Macleods Pharmaceuticals Limited	ANDA	Current
33342-025	Famciclovir	Famciclovir	Macleods Pharmaceuticals Limited	ANDA	Current
33342-025	Famciclovir	Famciclovir	Macleods Pharmaceuticals Limited	ANDA	Current
33342-026	Famciclovir	Famciclovir	Macleods Pharmaceuticals Limited	ANDA	Current
33342-026	Famciclovir	Famciclovir	Macleods Pharmaceuticals Limited	ANDA	Current
33342-026	Famciclovir	Famciclovir	Macleods Pharmaceuticals Limited	ANDA	Current
33342-026	Famciclovir	Famciclovir	Macleods Pharmaceuticals Limited	ANDA	Current
71205-609	Famciclovir	Famciclovir	Proficient Rx LP	ANDA	Current