Application 213079

Type: ANDA
Sponsor: PADAGIS ISRAEL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TAZAROTENE	TAZAROTENE	GEL;TOPICAL	0.05%	No	No
002	TAZAROTENE	TAZAROTENE	GEL;TOPICAL	0.1%	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A213079-001	TAZAROTENE	TAZAROTENE	0.05%	GEL / TOPICAL	AB		2023-04-25
A213079-002	TAZAROTENE	TAZAROTENE	0.1%	GEL / TOPICAL	AB		2023-04-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A213079-001	AB
A213079-002	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 · 46 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	A213079-001	TAZAROTENE	0.05%	GEL / TOPICAL	AB	2023-04-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213079-002	TAZAROTENE	0.1%	GEL / TOPICAL	AB	2023-04-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213079-001	TAZAROTENE	0.05%	GEL / TOPICAL	AB	2023-04-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213079-002	TAZAROTENE	0.1%	GEL / TOPICAL	AB	2023-04-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213079-001	TAZAROTENE	0.05%	GEL / TOPICAL	AB	2023-04-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213079-002	TAZAROTENE	0.1%	GEL / TOPICAL	AB	2023-04-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213079-001	TAZAROTENE	0.05%	GEL / TOPICAL	AB	2023-04-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213079-002	TAZAROTENE	0.1%	GEL / TOPICAL	AB	2023-04-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213079-001	TAZAROTENE	0.05%	GEL / TOPICAL	AB	2023-04-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213079-002	TAZAROTENE	0.1%	GEL / TOPICAL	AB	2023-04-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213079-001	TAZAROTENE	0.05%	GEL / TOPICAL	AB	2023-04-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213079-002	TAZAROTENE	0.1%	GEL / TOPICAL	AB	2023-04-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213079-001	TAZAROTENE	0.05%	GEL / TOPICAL	AB	2023-04-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213079-002	TAZAROTENE	0.1%	GEL / TOPICAL	AB	2023-04-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213079-001	TAZAROTENE	0.05%	GEL / TOPICAL	AB	2023-04-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213079-002	TAZAROTENE	0.1%	GEL / TOPICAL	AB	2023-04-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213079-001	TAZAROTENE	0.05%	GEL / TOPICAL	AB	2023-04-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213079-002	TAZAROTENE	0.1%	GEL / TOPICAL	AB	2023-04-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213079-001	TAZAROTENE	0.05%	GEL / TOPICAL	AB	2023-04-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213079-002	TAZAROTENE	0.1%	GEL / TOPICAL	AB	2023-04-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213079-001	TAZAROTENE	0.05%	GEL / TOPICAL	AB	2023-04-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213079-002	TAZAROTENE	0.1%	GEL / TOPICAL	AB	2023-04-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213079-001	TAZAROTENE	0.05%	GEL / TOPICAL	AB	2023-04-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213079-002	TAZAROTENE	0.1%	GEL / TOPICAL	AB	2023-04-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213079-001	TAZAROTENE	0.05%	GEL / TOPICAL	AB	2023-04-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213079-002	TAZAROTENE	0.1%	GEL / TOPICAL	AB	2023-04-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213079-001	TAZAROTENE	0.05%	GEL / TOPICAL	AB	2023-04-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213079-002	TAZAROTENE	0.1%	GEL / TOPICAL	AB	2023-04-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213079-001	TAZAROTENE	0.05%	GEL / TOPICAL	AB	2023-04-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213079-002	TAZAROTENE	0.1%	GEL / TOPICAL	AB	2023-04-25	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213079-001	TAZAROTENE	0.05%	GEL / TOPICAL	AB	2023-04-25	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213079-002	TAZAROTENE	0.1%	GEL / TOPICAL	AB	2023-04-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213079-001	TAZAROTENE	0.05%	GEL / TOPICAL	AB	2023-04-25	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A213079-002	TAZAROTENE	0.1%	GEL / TOPICAL	AB	2023-04-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213079-001	TAZAROTENE	0.05%	GEL / TOPICAL	AB	2023-04-25	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A213079-002	TAZAROTENE	0.1%	GEL / TOPICAL	AB	2023-04-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213079-001	TAZAROTENE	0.05%	GEL / TOPICAL	AB	2023-04-25	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213079-002	TAZAROTENE	0.1%	GEL / TOPICAL	AB	2023-04-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213079-001	TAZAROTENE	0.05%	GEL / TOPICAL	AB	2023-04-25	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213079-002	TAZAROTENE	0.1%	GEL / TOPICAL	AB	2023-04-25	`9b2671bbb829…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 46 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	A213079-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213079-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213079-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213079-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213079-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213079-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213079-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213079-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213079-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213079-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213079-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213079-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213079-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213079-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213079-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213079-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213079-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213079-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213079-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213079-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213079-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213079-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213079-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213079-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213079-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213079-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213079-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213079-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213079-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213079-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213079-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213079-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213079-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A213079-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213079-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A213079-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213079-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213079-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213079-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213079-002	AB	1	`9b2671bbb829…`

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
TAZAROTENE	TAZAROTENE	Bryant Ranch Prepack	aa6fff2f-01c7-4669-be67-07cec82c768a	2024-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213079 application number: ANDA213079
TAZAROTENE	TAZAROTENE	Padagis Israel Pharmaceuticals Ltd	ffd11dee-4266-4201-9573-1e82c2d30a63	2024-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213079 application number: ANDA213079