Application 021478

Type: NDA
Sponsor: BAUSCH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZOVIRAX	ACYCLOVIR	CREAM;TOPICAL	5%	Yes	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021478-001	ZOVIRAX	ACYCLOVIR	5%	CREAM / TOPICAL	AB	RLD	2002-12-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021478-001	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 2 · 42 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	N021478-001	ZOVIRAX	5%	CREAM / TOPICAL	AB	RLD	2002-12-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021478-001	ZOVIRAX	5%	CREAM / TOPICAL	AB	RLD	2002-12-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021478-001	ZOVIRAX	5%	CREAM / TOPICAL	AB	RLD	2002-12-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021478-001	ZOVIRAX	5%	CREAM / TOPICAL	AB	RLD	2002-12-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021478-001	ZOVIRAX	5%	CREAM / TOPICAL	AB	RLD	2002-12-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021478-001	ZOVIRAX	5%	CREAM / TOPICAL	AB	RLD	2002-12-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021478-001	ZOVIRAX	5%	CREAM / TOPICAL	AB	RLD	2002-12-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021478-001	ZOVIRAX	5%	CREAM / TOPICAL	AB	RLD	2002-12-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021478-001	ZOVIRAX	5%	CREAM / TOPICAL	AB	RLD	2002-12-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021478-001	ZOVIRAX	5%	CREAM / TOPICAL	AB	RLD	2002-12-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021478-001	ZOVIRAX	5%	CREAM / TOPICAL	AB	RLD	2002-12-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021478-001	ZOVIRAX	5%	CREAM / TOPICAL	AB	RLD	2002-12-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021478-001	ZOVIRAX	5%	CREAM / TOPICAL	AB	RLD	2002-12-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021478-001	ZOVIRAX	5%	CREAM / TOPICAL	AB	RLD	2002-12-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021478-001	ZOVIRAX	5%	CREAM / TOPICAL	AB	RLD	2002-12-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021478-001	ZOVIRAX	5%	CREAM / TOPICAL	AB	RLD	2002-12-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021478-001	ZOVIRAX	5%	CREAM / TOPICAL	AB	RLD	2002-12-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021478-001	ZOVIRAX	5%	CREAM / TOPICAL	AB	RLD	2002-12-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021478-001	ZOVIRAX	5%	CREAM / TOPICAL	AB	RLD, RS	2002-12-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021478-001	ZOVIRAX	5%	CREAM / TOPICAL	AB	RLD	2002-12-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021478-001	ZOVIRAX	5%	CREAM / TOPICAL	AB	RLD	2002-12-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021478-001	ZOVIRAX	5%	CREAM / TOPICAL	AB	RLD	2002-12-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021478-001	ZOVIRAX	5%	CREAM / TOPICAL	AB	RLD	2002-12-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021478-001	ZOVIRAX	5%	CREAM / TOPICAL	AB	RLD	2002-12-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021478-001	ZOVIRAX	5%	CREAM / TOPICAL	AB	RLD	2002-12-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021478-001	ZOVIRAX	5%	CREAM / TOPICAL	AB	RLD, RS	2002-12-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021478-001	ZOVIRAX	5%	CREAM / TOPICAL	AB	RLD, RS	2002-12-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021478-001	ZOVIRAX	5%	CREAM / TOPICAL	AB	RLD, RS	2002-12-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021478-001	ZOVIRAX	5%	CREAM / TOPICAL	AB	RLD	2002-12-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021478-001	ZOVIRAX	5%	CREAM / TOPICAL	AB	RLD	2002-12-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021478-001	ZOVIRAX	5%	CREAM / TOPICAL	AB	RLD	2002-12-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021478-001	ZOVIRAX	5%	CREAM / TOPICAL	AB	RLD	2002-12-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021478-001	ZOVIRAX	5%	CREAM / TOPICAL	AB	RLD	2002-12-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021478-001	ZOVIRAX	5%	CREAM / TOPICAL	AB	RLD	2002-12-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021478-001	ZOVIRAX	5%	CREAM / TOPICAL	AB	RLD	2002-12-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021478-001	ZOVIRAX	5%	CREAM / TOPICAL	AB	RLD	2002-12-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021478-001	ZOVIRAX	5%	CREAM / TOPICAL	AB	RLD	2002-12-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021478-001	ZOVIRAX	5%	CREAM / TOPICAL	AB	RLD	2002-12-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021478-001	ZOVIRAX	5%	CREAM / TOPICAL	AB	RLD	2002-12-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021478-001	ZOVIRAX	5%	CREAM / TOPICAL	AB	RLD	2002-12-30	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	N021478-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021478-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021478-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021478-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021478-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021478-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021478-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021478-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021478-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021478-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021478-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021478-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021478-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021478-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021478-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021478-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021478-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021478-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021478-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021478-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021478-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021478-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021478-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021478-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021478-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021478-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021478-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021478-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021478-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021478-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021478-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021478-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021478-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021478-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021478-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021478-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021478-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021478-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021478-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021478-001	AB	1	`e64feba35796…`

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
Acyclovir	ACYCLOVIR	Teva Pharmaceuticals USA, Inc.	103f29b8-2c13-4917-a446-59d3246d48d1	2025-10-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021478 application number: NDA021478 ndc (product): 0093-3630
Zovirax	ACYCLOVIR	Bausch Health US, LLC	125dbe4e-94ba-45bd-a714-f9c4b8e8b5c2	2021-02-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021478 application number: NDA021478 ndc (product): 0187-0994

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-3630	Acyclovir	acyclovir	Teva Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
0093-3630	Acyclovir	acyclovir	Teva Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
0093-3630	Acyclovir	acyclovir	Teva Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
0093-3630	Acyclovir	acyclovir	Teva Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
0187-0994	Zovirax	acyclovir	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-0994	Zovirax	acyclovir	Bausch Health Americas, Inc.	NDA	Current
0187-0994	Zovirax	acyclovir	Bausch Health US, LLC	NDA	Current
0187-0994	Zovirax	acyclovir	Bausch Health US, LLC	NDA	Current
42254-149	ZOVIRAX	acyclovir	Rebel Distributors Corp	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
65777	SUPPL	2020-12-29
65759	SUPPL	2020-12-28
53727	SUPPL	2018-04-18
5495	SUPPL	2014-04-03
15563	SUPPL	2014-04-02
21683	SUPPL	2006-10-25
5494	ORIG	2004-07-01
27895	SUPPL	2004-02-02
42188	ORIG	2003-07-08
37034	ORIG	2003-04-09