Application 077487

Type: ANDA
Sponsor: TEVA PHARMS

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	Yes

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	RLD / RS	Approval date
A077487-001	FAMCICLOVIR	FAMCICLOVIR	125MG	TABLET / ORAL	AB		2007-08-24
A077487-002	FAMCICLOVIR	FAMCICLOVIR	250MG	TABLET / ORAL	AB		2007-08-24
A077487-003	FAMCICLOVIR	FAMCICLOVIR	500MG	TABLET / ORAL	AB	RS	2007-08-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077487-001	AB
A077487-002	AB
A077487-003	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A077487-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB		2007-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077487-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB		2007-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077487-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	RS	2007-08-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077487-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB		2007-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077487-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB		2007-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077487-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	RS	2007-08-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077487-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB		2007-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077487-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB		2007-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077487-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	RS	2007-08-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077487-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB		2007-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077487-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB		2007-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077487-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	RS	2007-08-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077487-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB		2007-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077487-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB		2007-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077487-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	RS	2007-08-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077487-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB		2007-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077487-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB		2007-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077487-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	RS	2007-08-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077487-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB		2007-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077487-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB		2007-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077487-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	RS	2007-08-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077487-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB		2007-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077487-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB		2007-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077487-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	RS	2007-08-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077487-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB		2007-08-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077487-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB		2007-08-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077487-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	RS	2007-08-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077487-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB		2007-08-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077487-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB		2007-08-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077487-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	RS	2007-08-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077487-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB		2007-08-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077487-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB		2007-08-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077487-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	RS	2007-08-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077487-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB		2007-08-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077487-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB		2007-08-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077487-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	RS	2007-08-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077487-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB		2007-08-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077487-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB		2007-08-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077487-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	RS	2007-08-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077487-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB		2007-08-24	`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	A077487-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077487-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077487-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077487-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077487-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077487-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077487-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077487-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077487-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077487-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077487-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077487-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077487-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077487-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077487-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077487-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077487-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077487-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077487-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077487-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077487-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077487-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077487-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077487-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077487-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077487-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077487-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077487-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077487-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077487-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077487-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077487-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077487-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077487-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077487-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077487-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077487-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077487-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077487-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077487-001	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	AvKARE	c2b21ad5-fa83-1fb6-e053-2a95a90a3d0f	2026-01-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077487 application number: ANDA077487 ndc (product): 42291-414 ndc (product): 42291-416 ndc (product): 42291-415
Famciclovir	FAMCICLOVIR	PD-Rx Pharmaceuticals, Inc.	2c44b8d2-3b70-4e8b-af03-2e917178f761	2025-10-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077487 application number: ANDA077487 ndc (product): 55289-168
Famciclovir	FAMCICLOVIR	Teva Pharmaceuticals USA, Inc.	3f02042f-8f51-4ccf-b608-5dcd75d100fb	2022-11-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077487 application number: ANDA077487 ndc (product): 0093-8119 ndc (product): 0093-8118 ndc (product): 0093-8117

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-8117	Famciclovir	Famciclovir	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-8117	Famciclovir	Famciclovir	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-8117	Famciclovir	Famciclovir	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-8118	Famciclovir	Famciclovir	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-8118	Famciclovir	Famciclovir	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-8118	Famciclovir	Famciclovir	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-8119	Famciclovir	Famciclovir	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-8119	Famciclovir	Famciclovir	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-8119	Famciclovir	Famciclovir	Teva Pharmaceuticals USA, Inc.	ANDA	Current
42291-275	Famciclovir	Famciclovir	AvKARE, Inc.	ANDA	Current
42291-275	Famciclovir	Famciclovir	AvKARE, Inc.	ANDA	Current
42291-276	Famciclovir	Famciclovir	AvKARE, Inc.	ANDA	Current
42291-276	Famciclovir	Famciclovir	AvKARE, Inc.	ANDA	Current
42291-277	Famciclovir	Famciclovir	AvKARE, Inc.	ANDA	Current
42291-277	Famciclovir	Famciclovir	AvKARE, Inc.	ANDA	Current
42291-414	Famciclovir	Famciclovir	AvKARE	ANDA	Current
42291-414	Famciclovir	Famciclovir	AvKARE	ANDA	Current
42291-415	Famciclovir	Famciclovir	AvKARE	ANDA	Current
42291-415	Famciclovir	Famciclovir	AvKARE	ANDA	Current
42291-416	Famciclovir	Famciclovir	AvKARE	ANDA	Current
42291-416	Famciclovir	Famciclovir	AvKARE	ANDA	Current
55289-168	Famciclovir	Famciclovir	PD-Rx Pharmaceuticals, In	ANDA	Current
55289-168	Famciclovir	Famciclovir	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-168	Famciclovir	Famciclovir	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-168	Famciclovir	Famciclovir	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-168	Famciclovir	Famciclovir	PD-Rx Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31247	ORIG	2007-08-27
9052	ORIG	2007-07-05