Application 205063

Type: ANDA
Sponsor: ACTAVIS LABS FL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ISOTRETINOIN	ISOTRETINOIN	CAPSULE;ORAL	10MG	No	No
002	ISOTRETINOIN	ISOTRETINOIN	CAPSULE;ORAL	20MG	No	No
003	ISOTRETINOIN	ISOTRETINOIN	CAPSULE;ORAL	25MG	No	No
004	ISOTRETINOIN	ISOTRETINOIN	CAPSULE;ORAL	30MG	No	No
005	ISOTRETINOIN	ISOTRETINOIN	CAPSULE;ORAL	35MG	No	No
006	ISOTRETINOIN	ISOTRETINOIN	CAPSULE;ORAL	40MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A205063-001	ISOTRETINOIN	ISOTRETINOIN	10MG	CAPSULE / ORAL	AB2	2021-03-31
A205063-002	ISOTRETINOIN	ISOTRETINOIN	20MG	CAPSULE / ORAL	AB2	2021-03-31
A205063-003	ISOTRETINOIN	ISOTRETINOIN	25MG	CAPSULE / ORAL	AB2	2021-03-31
A205063-004	ISOTRETINOIN	ISOTRETINOIN	30MG	CAPSULE / ORAL	AB2	2021-03-31
A205063-005	ISOTRETINOIN	ISOTRETINOIN	35MG	CAPSULE / ORAL	AB2	2021-03-31
A205063-006	ISOTRETINOIN	ISOTRETINOIN	40MG	CAPSULE / ORAL	AB2	2021-03-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A205063-001	AB2
A205063-002	AB2
A205063-003	AB2
A205063-004	AB2
A205063-005	AB2
A205063-006	AB2

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 6 · 204 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
2026-02-19 14:30 UTC	2026-02	A205063-001	ISOTRETINOIN	10MG	CAPSULE / ORAL	AB2	2021-03-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205063-002	ISOTRETINOIN	20MG	CAPSULE / ORAL	AB2	2021-03-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205063-003	ISOTRETINOIN	25MG	CAPSULE / ORAL	AB2	2021-03-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205063-004	ISOTRETINOIN	30MG	CAPSULE / ORAL	AB2	2021-03-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205063-005	ISOTRETINOIN	35MG	CAPSULE / ORAL	AB2	2021-03-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205063-006	ISOTRETINOIN	40MG	CAPSULE / ORAL	AB2	2021-03-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205063-001	ISOTRETINOIN	10MG	CAPSULE / ORAL	AB2	2021-03-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205063-002	ISOTRETINOIN	20MG	CAPSULE / ORAL	AB2	2021-03-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205063-003	ISOTRETINOIN	25MG	CAPSULE / ORAL	AB2	2021-03-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205063-004	ISOTRETINOIN	30MG	CAPSULE / ORAL	AB2	2021-03-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205063-005	ISOTRETINOIN	35MG	CAPSULE / ORAL	AB2	2021-03-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205063-006	ISOTRETINOIN	40MG	CAPSULE / ORAL	AB2	2021-03-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205063-001	ISOTRETINOIN	10MG	CAPSULE / ORAL	AB2	2021-03-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205063-002	ISOTRETINOIN	20MG	CAPSULE / ORAL	AB2	2021-03-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205063-003	ISOTRETINOIN	25MG	CAPSULE / ORAL	AB2	2021-03-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205063-004	ISOTRETINOIN	30MG	CAPSULE / ORAL	AB2	2021-03-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205063-005	ISOTRETINOIN	35MG	CAPSULE / ORAL	AB2	2021-03-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205063-006	ISOTRETINOIN	40MG	CAPSULE / ORAL	AB2	2021-03-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205063-001	ISOTRETINOIN	10MG	CAPSULE / ORAL	AB2	2021-03-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205063-002	ISOTRETINOIN	20MG	CAPSULE / ORAL	AB2	2021-03-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205063-003	ISOTRETINOIN	25MG	CAPSULE / ORAL	AB2	2021-03-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205063-004	ISOTRETINOIN	30MG	CAPSULE / ORAL	AB2	2021-03-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205063-005	ISOTRETINOIN	35MG	CAPSULE / ORAL	AB2	2021-03-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205063-006	ISOTRETINOIN	40MG	CAPSULE / ORAL	AB2	2021-03-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205063-001	ISOTRETINOIN	10MG	CAPSULE / ORAL	AB2	2021-03-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205063-002	ISOTRETINOIN	20MG	CAPSULE / ORAL	AB2	2021-03-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205063-003	ISOTRETINOIN	25MG	CAPSULE / ORAL	AB2	2021-03-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205063-004	ISOTRETINOIN	30MG	CAPSULE / ORAL	AB2	2021-03-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205063-005	ISOTRETINOIN	35MG	CAPSULE / ORAL	AB2	2021-03-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205063-006	ISOTRETINOIN	40MG	CAPSULE / ORAL	AB2	2021-03-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205063-001	ISOTRETINOIN	10MG	CAPSULE / ORAL	AB2	2021-03-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205063-002	ISOTRETINOIN	20MG	CAPSULE / ORAL	AB2	2021-03-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205063-003	ISOTRETINOIN	25MG	CAPSULE / ORAL	AB2	2021-03-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205063-004	ISOTRETINOIN	30MG	CAPSULE / ORAL	AB2	2021-03-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205063-005	ISOTRETINOIN	35MG	CAPSULE / ORAL	AB2	2021-03-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205063-006	ISOTRETINOIN	40MG	CAPSULE / ORAL	AB2	2021-03-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205063-001	ISOTRETINOIN	10MG	CAPSULE / ORAL	AB2	2021-03-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205063-002	ISOTRETINOIN	20MG	CAPSULE / ORAL	AB2	2021-03-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205063-003	ISOTRETINOIN	25MG	CAPSULE / ORAL	AB2	2021-03-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205063-004	ISOTRETINOIN	30MG	CAPSULE / ORAL	AB2	2021-03-31	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 204 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A205063-001	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205063-002	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205063-003	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205063-004	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205063-005	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205063-006	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205063-001	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205063-002	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205063-003	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205063-004	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205063-005	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205063-006	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205063-001	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205063-002	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205063-003	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205063-004	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205063-005	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205063-006	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205063-001	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205063-002	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205063-003	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205063-004	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205063-005	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205063-006	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205063-001	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205063-002	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205063-003	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205063-004	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205063-005	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205063-006	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205063-001	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205063-002	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205063-003	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205063-004	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205063-005	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205063-006	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205063-001	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205063-002	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205063-003	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205063-004	AB2	1	`2680178bc6a6…`

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
Isotretinoin	ISOTRETINOIN	Actavis Pharma, Inc.	1cf11710-f966-4529-8e08-02175f588bca	2025-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205063 application number: ANDA205063 ndc (product): 0591-2434 ndc (product): 0591-2435 ndc (product): 0591-2451 ndc (product): 0591-2433 ndc (product): 0591-2501 ndc (product): 0591-2436

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0591-2433	Isotretinoin	Isotretinoin	Actavis Pharma, Inc.	ANDA	Current
0591-2434	Isotretinoin	Isotretinoin	Actavis Pharma, Inc.	ANDA	Current
0591-2435	Isotretinoin	Isotretinoin	Actavis Pharma, Inc.	ANDA	Current
0591-2436	Isotretinoin	Isotretinoin	Actavis Pharma, Inc.	ANDA	Current
0591-2451	Isotretinoin	Isotretinoin	Actavis Pharma, Inc.	ANDA	Current
0591-2501	Isotretinoin	Isotretinoin	Actavis Pharma, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76354	ORIG	2023-11-06