Application 078278

Type: ANDA
Sponsor: CIPLA

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	Approval date
A078278-001	FAMCICLOVIR	FAMCICLOVIR	125MG	TABLET / ORAL	2011-03-21
A078278-002	FAMCICLOVIR	FAMCICLOVIR	250MG	TABLET / ORAL	2011-03-21
A078278-003	FAMCICLOVIR	FAMCICLOVIR	500MG	TABLET / ORAL	2011-03-21

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A078278-001	FAMCICLOVIR	125MG	TABLET / ORAL	2011-03-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078278-002	FAMCICLOVIR	250MG	TABLET / ORAL	2011-03-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078278-003	FAMCICLOVIR	500MG	TABLET / ORAL	2011-03-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078278-001	FAMCICLOVIR	125MG	TABLET / ORAL	2011-03-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078278-002	FAMCICLOVIR	250MG	TABLET / ORAL	2011-03-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078278-003	FAMCICLOVIR	500MG	TABLET / ORAL	2011-03-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078278-001	FAMCICLOVIR	125MG	TABLET / ORAL	2011-03-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078278-002	FAMCICLOVIR	250MG	TABLET / ORAL	2011-03-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078278-003	FAMCICLOVIR	500MG	TABLET / ORAL	2011-03-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078278-001	FAMCICLOVIR	125MG	TABLET / ORAL	2011-03-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078278-002	FAMCICLOVIR	250MG	TABLET / ORAL	2011-03-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078278-003	FAMCICLOVIR	500MG	TABLET / ORAL	2011-03-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078278-001	FAMCICLOVIR	125MG	TABLET / ORAL	2011-03-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078278-002	FAMCICLOVIR	250MG	TABLET / ORAL	2011-03-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078278-003	FAMCICLOVIR	500MG	TABLET / ORAL	2011-03-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078278-001	FAMCICLOVIR	125MG	TABLET / ORAL	2011-03-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078278-002	FAMCICLOVIR	250MG	TABLET / ORAL	2011-03-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078278-003	FAMCICLOVIR	500MG	TABLET / ORAL	2011-03-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078278-001	FAMCICLOVIR	125MG	TABLET / ORAL	2011-03-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078278-002	FAMCICLOVIR	250MG	TABLET / ORAL	2011-03-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078278-003	FAMCICLOVIR	500MG	TABLET / ORAL	2011-03-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078278-001	FAMCICLOVIR	125MG	TABLET / ORAL	2011-03-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078278-002	FAMCICLOVIR	250MG	TABLET / ORAL	2011-03-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078278-003	FAMCICLOVIR	500MG	TABLET / ORAL	2011-03-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078278-001	FAMCICLOVIR	125MG	TABLET / ORAL	2011-03-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078278-002	FAMCICLOVIR	250MG	TABLET / ORAL	2011-03-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078278-003	FAMCICLOVIR	500MG	TABLET / ORAL	2011-03-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078278-001	FAMCICLOVIR	125MG	TABLET / ORAL	2011-03-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078278-002	FAMCICLOVIR	250MG	TABLET / ORAL	2011-03-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078278-003	FAMCICLOVIR	500MG	TABLET / ORAL	2011-03-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078278-001	FAMCICLOVIR	125MG	TABLET / ORAL	2011-03-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078278-002	FAMCICLOVIR	250MG	TABLET / ORAL	2011-03-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078278-003	FAMCICLOVIR	500MG	TABLET / ORAL	2011-03-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078278-001	FAMCICLOVIR	125MG	TABLET / ORAL	2011-03-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078278-002	FAMCICLOVIR	250MG	TABLET / ORAL	2011-03-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078278-003	FAMCICLOVIR	500MG	TABLET / ORAL	2011-03-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078278-001	FAMCICLOVIR	125MG	TABLET / ORAL	2011-03-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078278-002	FAMCICLOVIR	250MG	TABLET / ORAL	2011-03-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078278-003	FAMCICLOVIR	500MG	TABLET / ORAL	2011-03-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078278-001	FAMCICLOVIR	125MG	TABLET / ORAL	2011-03-21	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-04 05:41 UTC	2022-04	A078278-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078278-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078278-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078278-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078278-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078278-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078278-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078278-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078278-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078278-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078278-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078278-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078278-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078278-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078278-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078278-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078278-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078278-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078278-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078278-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078278-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078278-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078278-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078278-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078278-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078278-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078278-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078278-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078278-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078278-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078278-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078278-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078278-003	AB	1	`ea99ee380514…`

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 · 12 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	Name fallback brand name: Famciclovir generic name: FAMCICLOVIR
Famciclovir	FAMCICLOVIR	AvKARE	c2b21ad5-fa83-1fb6-e053-2a95a90a3d0f	2026-01-14	Warnings, Adverse reactions	Name fallback brand name: Famciclovir generic name: FAMCICLOVIR
Famciclovir	FAMCICLOVIR	Bryant Ranch Prepack	d3faac3a-5c8c-4987-9703-c161fb29ec56	2025-10-28	Warnings, Adverse reactions	Name fallback brand name: Famciclovir generic name: FAMCICLOVIR
Famciclovir	FAMCICLOVIR	PD-Rx Pharmaceuticals, Inc.	2c44b8d2-3b70-4e8b-af03-2e917178f761	2025-10-20	Warnings, Adverse reactions	Name fallback brand name: Famciclovir generic name: FAMCICLOVIR
Famciclovir	FAMCICLOVIR	Macleods Pharmaceuticals Limited	eeeee9c4-8566-4100-8ca4-3df936a3365d	2025-09-17	Warnings, Adverse reactions	Name fallback brand name: Famciclovir generic name: FAMCICLOVIR
Famciclovir	FAMCICLOVIR	Bryant Ranch Prepack	2c579bc7-8130-4935-a999-62b4b1c20706	2025-03-25	Warnings, Adverse reactions	Name fallback brand name: Famciclovir generic name: FAMCICLOVIR
Famciclovir	FAMCICLOVIR	Camber Pharmaceuticals, Inc.	08c58224-5920-4853-8c59-ec5fbb66c2f6	2025-01-09	Warnings, Adverse reactions	Name fallback brand name: Famciclovir generic name: FAMCICLOVIR
Famciclovir	FAMCICLOVIR	Aurobindo Pharma Limited	fcf0b0fa-bb2c-4f2c-aa9f-1f2da65d8343	2024-06-15	Warnings, Adverse reactions	Name fallback brand name: Famciclovir generic name: FAMCICLOVIR
Famciclovir	FAMCICLOVIR	Rising Pharma Holdings, Inc.	d5c46506-a350-44a1-9440-d939da895f16	2024-06-15	Warnings, Adverse reactions	Name fallback brand name: Famciclovir generic name: FAMCICLOVIR
Famciclovir	FAMCICLOVIR	Proficient Rx LP	b75abffb-0a90-4abd-8ed8-81be1d8fe364	2023-01-01	Warnings, Adverse reactions	Name fallback brand name: Famciclovir generic name: FAMCICLOVIR
Famciclovir	FAMCICLOVIR	Teva Pharmaceuticals USA, Inc.	3f02042f-8f51-4ccf-b608-5dcd75d100fb	2022-11-28	Warnings, Adverse reactions	Name fallback brand name: Famciclovir generic name: FAMCICLOVIR
Famciclovir	FAMCICLOVIR	Proficient Rx LP	29b7ea8b-b976-45cb-9006-a27ba797b0fd	2022-06-01	Warnings, Adverse reactions	Name fallback brand name: Famciclovir generic name: FAMCICLOVIR

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-614	Famciclovir	Famciclovir	NorthStar RxLLC	ANDA	Current
16714-614	Famciclovir	Famciclovir	NorthStar RxLLC	ANDA	Current
16714-615	Famciclovir	Famciclovir	NorthStar RxLLC	ANDA	Current
16714-615	Famciclovir	Famciclovir	NorthStar RxLLC	ANDA	Current
16714-616	Famciclovir	Famciclovir	NorthStar RxLLC	ANDA	Current
16714-616	Famciclovir	Famciclovir	NorthStar RxLLC	ANDA	Current
50090-3066	Famciclovir	Famciclovir	A-S Medication Solutions	ANDA	Current
63187-919	FAMCICLOVIR	Famciclovir	Proficient Rx LP	ANDA	Current
63187-919	FAMCICLOVIR	Famciclovir	Proficient Rx LP	ANDA	Current
63187-920	FAMCICLOVIR	Famciclovir	Proficient Rx LP	ANDA	Current
63187-920	FAMCICLOVIR	Famciclovir	Proficient Rx LP	ANDA	Current
69097-269	FAMCICLOVIR	Famciclovir	Cipla USA Inc.	ANDA	Current
69097-269	FAMCICLOVIR	Famciclovir	Cipla USA Inc.	ANDA	Current
69097-269	FAMCICLOVIR	Famciclovir	Cipla USA Inc.	ANDA	Current
69097-271	FAMCICLOVIR	Famciclovir	Cipla USA Inc.	ANDA	Current
69097-271	FAMCICLOVIR	Famciclovir	Cipla USA Inc.	ANDA	Current
69097-271	FAMCICLOVIR	Famciclovir	Cipla USA Inc.	ANDA	Current
69097-272	FAMCICLOVIR	Famciclovir	Cipla USA Inc.	ANDA	Current
69097-272	FAMCICLOVIR	Famciclovir	Cipla USA Inc.	ANDA	Current
69097-272	FAMCICLOVIR	Famciclovir	Cipla USA Inc.	ANDA	Current