Application 019795

Type: NDA
Sponsor: TEVA BRANDED PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CONDYLOX	PODOFILOX	SOLUTION;TOPICAL	0.5%	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N019795-001	CONDYLOX	PODOFILOX	0.5%	SOLUTION / TOPICAL		RLD	1990-12-13

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 · 41 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
2026-02-19 14:30 UTC	2026-02	N019795-001	CONDYLOX	0.5%	SOLUTION / TOPICAL	AT	RLD, RS	1990-12-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019795-001	CONDYLOX	0.5%	SOLUTION / TOPICAL	AT	RLD, RS	1990-12-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019795-001	CONDYLOX	0.5%	SOLUTION / TOPICAL	AT	RLD, RS	1990-12-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019795-001	CONDYLOX	0.5%	SOLUTION / TOPICAL	AT	RLD, RS	1990-12-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019795-001	CONDYLOX	0.5%	SOLUTION / TOPICAL	AT	RLD, RS	1990-12-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019795-001	CONDYLOX	0.5%	SOLUTION / TOPICAL	AT	RLD, RS	1990-12-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019795-001	CONDYLOX	0.5%	SOLUTION / TOPICAL	AT	RLD, RS	1990-12-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019795-001	CONDYLOX	0.5%	SOLUTION / TOPICAL	AT	RLD, RS	1990-12-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019795-001	CONDYLOX	0.5%	SOLUTION / TOPICAL	AT	RLD, RS	1990-12-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019795-001	CONDYLOX	0.5%	SOLUTION / TOPICAL	AT	RLD, RS	1990-12-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019795-001	CONDYLOX	0.5%	SOLUTION / TOPICAL	AT	RLD, RS	1990-12-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019795-001	CONDYLOX	0.5%	SOLUTION / TOPICAL	AT	RLD, RS	1990-12-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019795-001	CONDYLOX	0.5%	SOLUTION / TOPICAL	AT	RLD, RS	1990-12-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019795-001	CONDYLOX	0.5%	SOLUTION / TOPICAL	AT	RLD, RS	1990-12-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019795-001	CONDYLOX	0.5%	SOLUTION / TOPICAL	AT	RLD, RS	1990-12-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019795-001	CONDYLOX	0.5%	SOLUTION / TOPICAL	AT	RLD, RS	1990-12-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019795-001	CONDYLOX	0.5%	SOLUTION / TOPICAL	AT	RLD, RS	1990-12-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019795-001	CONDYLOX	0.5%	SOLUTION / TOPICAL	AT	RLD, RS	1990-12-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019795-001	CONDYLOX	0.5%	SOLUTION / TOPICAL	AT	RLD, RS	1990-12-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019795-001	CONDYLOX	0.5%	SOLUTION / TOPICAL	AT	RLD, RS	1990-12-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019795-001	CONDYLOX	0.5%	SOLUTION / TOPICAL	AT	RLD, RS	1990-12-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019795-001	CONDYLOX	0.5%	SOLUTION / TOPICAL	AT	RLD, RS	1990-12-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019795-001	CONDYLOX	0.5%	SOLUTION / TOPICAL	AT	RLD, RS	1990-12-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019795-001	CONDYLOX	0.5%	SOLUTION / TOPICAL	AT	RLD, RS	1990-12-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019795-001	CONDYLOX	0.5%	SOLUTION / TOPICAL	AT	RLD, RS	1990-12-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019795-001	CONDYLOX	0.5%	SOLUTION / TOPICAL	AT	RLD, RS	1990-12-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019795-001	CONDYLOX	0.5%	SOLUTION / TOPICAL	AT	RLD, RS	1990-12-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019795-001	CONDYLOX	0.5%	SOLUTION / TOPICAL	AT	RLD, RS	1990-12-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019795-001	CONDYLOX	0.5%	SOLUTION / TOPICAL	AT	RLD, RS	1990-12-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019795-001	CONDYLOX	0.5%	SOLUTION / TOPICAL	AT	RLD, RS	1990-12-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019795-001	CONDYLOX	0.5%	SOLUTION / TOPICAL	AT	RLD, RS	1990-12-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019795-001	CONDYLOX	0.5%	SOLUTION / TOPICAL	AT	RLD, RS	1990-12-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019795-001	CONDYLOX	0.5%	SOLUTION / TOPICAL	AT	RLD, RS	1990-12-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019795-001	CONDYLOX	0.5%	SOLUTION / TOPICAL	AT	RLD, RS	1990-12-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019795-001	CONDYLOX	0.5%	SOLUTION / TOPICAL	AT	RLD, RS	1990-12-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019795-001	CONDYLOX	0.5%	SOLUTION / TOPICAL	AT	RLD, RS	1990-12-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019795-001	CONDYLOX	0.5%	SOLUTION / TOPICAL	AT	RLD, RS	1990-12-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019795-001	CONDYLOX	0.5%	SOLUTION / TOPICAL	AT	RLD, RS	1990-12-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019795-001	CONDYLOX	0.5%	SOLUTION / TOPICAL	AT	RLD, RS	1990-12-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019795-001	CONDYLOX	0.5%	SOLUTION / TOPICAL	AT	RLD, RS	1990-12-13	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N019795-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019795-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019795-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019795-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019795-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019795-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019795-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019795-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019795-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019795-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019795-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019795-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019795-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019795-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019795-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019795-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019795-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019795-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019795-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019795-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019795-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019795-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019795-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019795-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019795-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019795-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019795-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019795-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019795-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019795-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019795-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019795-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019795-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019795-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019795-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019795-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019795-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019795-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019795-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019795-001	AT	1	`cb3db0bc1861…`

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
Condylox	PODOFILOX	Allergan, Inc.	032e4bcb-b1ed-4029-b2a6-e92f3bf5cc37	2024-01-29	Warnings, Adverse reactions	Name fallback brand name: Condylox generic name: PODOFILOX
Podofilox	PODOFILOX	Padagis US LLC	d2e70c5e-d4a9-4295-9eff-517ffb974e61	2023-05-01	Warnings, Adverse reactions	Name fallback generic name: PODOFILOX
PODOFILOX	PODOFILOX	Padagis US LLC	6af07697-5203-43e0-ba35-83683af851c3	2023-02-28	Warnings, Adverse reactions	Name fallback generic name: PODOFILOX

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
0591-3204	Podofilox	Podofilox	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-3204	Podofilox	Podofilox	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-3204	Podofilox	Podofilox	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-3204	Podofilox	Podofilox	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-3204	Podofilox	Podofilox	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-3204	Podofilox	Podofilox	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
63629-8832	Podofilox	Podofilox	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-8832	Podofilox	Podofilox	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-8832	Podofilox	Podofilox	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current