Application 076135

Type: ANDA
Sponsor: TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLARAVIS	ISOTRETINOIN	CAPSULE;ORAL	40MG	No	Yes
002	CLARAVIS	ISOTRETINOIN	CAPSULE;ORAL	20MG	No	No
003	CLARAVIS	ISOTRETINOIN	CAPSULE;ORAL	30MG	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	TE codes	RLD / RS	Approval date
A076135-001	CLARAVIS	ISOTRETINOIN	40MG	CAPSULE / ORAL	AB1	RS	2003-04-11
A076135-002	CLARAVIS	ISOTRETINOIN	20MG	CAPSULE / ORAL	AB1		2003-04-11
A076135-003	CLARAVIS	ISOTRETINOIN	30MG	CAPSULE / ORAL	AB1		2006-05-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076135-001	AB1
A076135-002	AB1
A076135-003	AB1

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	A076135-001	CLARAVIS	40MG	CAPSULE / ORAL	AB1	RS	2003-04-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076135-002	CLARAVIS	20MG	CAPSULE / ORAL	AB1		2003-04-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076135-003	CLARAVIS	30MG	CAPSULE / ORAL	AB1		2006-05-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076135-001	CLARAVIS	40MG	CAPSULE / ORAL	AB1	RS	2003-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076135-002	CLARAVIS	20MG	CAPSULE / ORAL	AB1		2003-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076135-003	CLARAVIS	30MG	CAPSULE / ORAL	AB1		2006-05-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076135-001	CLARAVIS	40MG	CAPSULE / ORAL	AB1	RS	2003-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076135-002	CLARAVIS	20MG	CAPSULE / ORAL	AB1		2003-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076135-003	CLARAVIS	30MG	CAPSULE / ORAL	AB1		2006-05-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076135-001	CLARAVIS	40MG	CAPSULE / ORAL	AB1	RS	2003-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076135-002	CLARAVIS	20MG	CAPSULE / ORAL	AB1		2003-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076135-003	CLARAVIS	30MG	CAPSULE / ORAL	AB1		2006-05-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076135-001	CLARAVIS	40MG	CAPSULE / ORAL	AB1	RS	2003-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076135-002	CLARAVIS	20MG	CAPSULE / ORAL	AB1		2003-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076135-003	CLARAVIS	30MG	CAPSULE / ORAL	AB1		2006-05-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076135-001	CLARAVIS	40MG	CAPSULE / ORAL	AB1	RS	2003-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076135-002	CLARAVIS	20MG	CAPSULE / ORAL	AB1		2003-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076135-003	CLARAVIS	30MG	CAPSULE / ORAL	AB1		2006-05-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076135-001	CLARAVIS	40MG	CAPSULE / ORAL	AB1	RS	2003-04-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076135-002	CLARAVIS	20MG	CAPSULE / ORAL	AB1		2003-04-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076135-003	CLARAVIS	30MG	CAPSULE / ORAL	AB1		2006-05-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076135-001	CLARAVIS	40MG	CAPSULE / ORAL	AB1	RS	2003-04-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076135-002	CLARAVIS	20MG	CAPSULE / ORAL	AB1		2003-04-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076135-003	CLARAVIS	30MG	CAPSULE / ORAL	AB1		2006-05-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076135-001	CLARAVIS	40MG	CAPSULE / ORAL	AB1	RS	2003-04-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076135-002	CLARAVIS	20MG	CAPSULE / ORAL	AB1		2003-04-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076135-003	CLARAVIS	30MG	CAPSULE / ORAL	AB1		2006-05-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076135-001	CLARAVIS	40MG	CAPSULE / ORAL	AB1	RS	2003-04-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076135-002	CLARAVIS	20MG	CAPSULE / ORAL	AB1		2003-04-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076135-003	CLARAVIS	30MG	CAPSULE / ORAL	AB1		2006-05-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076135-001	CLARAVIS	40MG	CAPSULE / ORAL	AB1	RS	2003-04-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076135-002	CLARAVIS	20MG	CAPSULE / ORAL	AB1		2003-04-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076135-003	CLARAVIS	30MG	CAPSULE / ORAL	AB1		2006-05-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076135-001	CLARAVIS	40MG	CAPSULE / ORAL	AB1	RS	2003-04-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076135-002	CLARAVIS	20MG	CAPSULE / ORAL	AB1		2003-04-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076135-003	CLARAVIS	30MG	CAPSULE / ORAL	AB1		2006-05-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076135-001	CLARAVIS	40MG	CAPSULE / ORAL	AB1	RS	2003-04-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076135-002	CLARAVIS	20MG	CAPSULE / ORAL	AB1		2003-04-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076135-003	CLARAVIS	30MG	CAPSULE / ORAL	AB1		2006-05-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076135-001	CLARAVIS	40MG	CAPSULE / ORAL	AB1	RS	2003-04-11	`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	A076135-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076135-002	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076135-003	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076135-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076135-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076135-003	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076135-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076135-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076135-003	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076135-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076135-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076135-003	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076135-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076135-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076135-003	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076135-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076135-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076135-003	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076135-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076135-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076135-003	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076135-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076135-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076135-003	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076135-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076135-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076135-003	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076135-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076135-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076135-003	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076135-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076135-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076135-003	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076135-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076135-002	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076135-003	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076135-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076135-002	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076135-003	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076135-001	AB1	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Claravis	ISOTRETINOIN	Teva Pharmaceuticals USA, Inc.	a31fd109-d0fd-4ab9-ba98-a3d64333c18d	2026-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076135 application number: ANDA076135 ndc (product): 0555-1055 ndc (product): 0555-1057 ndc (product): 0555-1056

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0555-1055	Claravis	Isotretinoin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-1055	Claravis	Isotretinoin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-1055	Claravis	Isotretinoin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-1055	Claravis	Isotretinoin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-1055	Claravis	Isotretinoin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-1055	Claravis	Isotretinoin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-1056	Claravis	Isotretinoin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-1056	Claravis	Isotretinoin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-1056	Claravis	Isotretinoin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-1056	Claravis	Isotretinoin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-1056	Claravis	Isotretinoin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-1056	Claravis	Isotretinoin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-1057	Claravis	Isotretinoin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-1057	Claravis	Isotretinoin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-1057	Claravis	Isotretinoin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-1057	Claravis	Isotretinoin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-1057	Claravis	Isotretinoin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-1057	Claravis	Isotretinoin	Teva Pharmaceuticals USA, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
24052	ORIG	2015-07-02
44289	ORIG	2005-07-28