Application 218194

Type: ANDA
Sponsor: AUROBINDO PHARMA

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 43.

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
A218194-001	ISOTRETINOIN	ISOTRETINOIN	10MG	CAPSULE / ORAL	AB2	2024-01-29
A218194-002	ISOTRETINOIN	ISOTRETINOIN	20MG	CAPSULE / ORAL	AB2	2024-01-29
A218194-003	ISOTRETINOIN	ISOTRETINOIN	25MG	CAPSULE / ORAL	AB2	2024-01-29
A218194-004	ISOTRETINOIN	ISOTRETINOIN	30MG	CAPSULE / ORAL	AB2	2024-01-29
A218194-005	ISOTRETINOIN	ISOTRETINOIN	35MG	CAPSULE / ORAL	AB2	2024-01-29
A218194-006	ISOTRETINOIN	ISOTRETINOIN	40MG	CAPSULE / ORAL	AB2	2024-01-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A218194-001	AB2
A218194-002	AB2
A218194-003	AB2
A218194-004	AB2
A218194-005	AB2
A218194-006	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 3 · 114 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
2026-09-14 22:38:34	2026-08	A218194-001	ISOTRETINOIN	10MG	CAPSULE / ORAL	AB2	2024-01-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218194-002	ISOTRETINOIN	20MG	CAPSULE / ORAL	AB2	2024-01-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218194-003	ISOTRETINOIN	25MG	CAPSULE / ORAL	AB2	2024-01-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218194-004	ISOTRETINOIN	30MG	CAPSULE / ORAL	AB2	2024-01-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218194-005	ISOTRETINOIN	35MG	CAPSULE / ORAL	AB2	2024-01-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218194-006	ISOTRETINOIN	40MG	CAPSULE / ORAL	AB2	2024-01-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218194-001	ISOTRETINOIN	10MG	CAPSULE / ORAL	AB2	2024-01-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218194-002	ISOTRETINOIN	20MG	CAPSULE / ORAL	AB2	2024-01-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218194-003	ISOTRETINOIN	25MG	CAPSULE / ORAL	AB2	2024-01-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218194-004	ISOTRETINOIN	30MG	CAPSULE / ORAL	AB2	2024-01-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218194-005	ISOTRETINOIN	35MG	CAPSULE / ORAL	AB2	2024-01-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218194-006	ISOTRETINOIN	40MG	CAPSULE / ORAL	AB2	2024-01-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218194-001	ISOTRETINOIN	10MG	CAPSULE / ORAL	AB2	2024-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218194-002	ISOTRETINOIN	20MG	CAPSULE / ORAL	AB2	2024-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218194-003	ISOTRETINOIN	25MG	CAPSULE / ORAL	AB2	2024-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218194-004	ISOTRETINOIN	30MG	CAPSULE / ORAL	AB2	2024-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218194-005	ISOTRETINOIN	35MG	CAPSULE / ORAL	AB2	2024-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218194-006	ISOTRETINOIN	40MG	CAPSULE / ORAL	AB2	2024-01-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218194-001	ISOTRETINOIN	10MG	CAPSULE / ORAL	AB2	2024-01-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218194-002	ISOTRETINOIN	20MG	CAPSULE / ORAL	AB2	2024-01-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218194-003	ISOTRETINOIN	25MG	CAPSULE / ORAL	AB2	2024-01-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218194-004	ISOTRETINOIN	30MG	CAPSULE / ORAL	AB2	2024-01-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218194-005	ISOTRETINOIN	35MG	CAPSULE / ORAL	AB2	2024-01-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218194-006	ISOTRETINOIN	40MG	CAPSULE / ORAL	AB2	2024-01-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218194-001	ISOTRETINOIN	10MG	CAPSULE / ORAL	AB2	2024-01-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218194-002	ISOTRETINOIN	20MG	CAPSULE / ORAL	AB2	2024-01-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218194-003	ISOTRETINOIN	25MG	CAPSULE / ORAL	AB2	2024-01-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218194-004	ISOTRETINOIN	30MG	CAPSULE / ORAL	AB2	2024-01-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218194-005	ISOTRETINOIN	35MG	CAPSULE / ORAL	AB2	2024-01-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218194-006	ISOTRETINOIN	40MG	CAPSULE / ORAL	AB2	2024-01-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218194-001	ISOTRETINOIN	10MG	CAPSULE / ORAL	AB2	2024-01-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218194-002	ISOTRETINOIN	20MG	CAPSULE / ORAL	AB2	2024-01-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218194-003	ISOTRETINOIN	25MG	CAPSULE / ORAL	AB2	2024-01-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218194-004	ISOTRETINOIN	30MG	CAPSULE / ORAL	AB2	2024-01-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218194-005	ISOTRETINOIN	35MG	CAPSULE / ORAL	AB2	2024-01-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218194-006	ISOTRETINOIN	40MG	CAPSULE / ORAL	AB2	2024-01-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218194-001	ISOTRETINOIN	10MG	CAPSULE / ORAL	AB2	2024-01-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218194-002	ISOTRETINOIN	20MG	CAPSULE / ORAL	AB2	2024-01-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218194-003	ISOTRETINOIN	25MG	CAPSULE / ORAL	AB2	2024-01-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218194-004	ISOTRETINOIN	30MG	CAPSULE / ORAL	AB2	2024-01-29	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 3 · 114 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A218194-003	AB2	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A218194-004	AB2	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A218194-005	AB2	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A218194-006	AB2	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A218194-001	AB2	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A218194-002	AB2	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A218194-003	AB2	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A218194-004	AB2	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A218194-005	AB2	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A218194-006	AB2	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A218194-001	AB2	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A218194-002	AB2	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A218194-003	AB2	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A218194-004	AB2	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A218194-005	AB2	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A218194-006	AB2	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A218194-001	AB2	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A218194-002	AB2	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A218194-003	AB2	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A218194-004	AB2	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A218194-005	AB2	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A218194-006	AB2	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A218194-001	AB2	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A218194-002	AB2	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A218194-003	AB2	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A218194-004	AB2	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A218194-005	AB2	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A218194-006	AB2	1	`1c564ffb4f44…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218194-001	AB2	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218194-002	AB2	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218194-003	AB2	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218194-004	AB2	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218194-005	AB2	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218194-006	AB2	1	`a50c72e98297…`

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 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Isotretinoin	ISOTRETINOIN	Amneal Pharmaceuticals LLC	c2917c3d-3499-48a0-ba53-120cb979195d	2026-08-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Isotretinoin generic name: ISOTRETINOIN
Isotretinoin	ISOTRETINOIN	Zydus Pharmaceuticals USA Inc.	31f62a49-4c6d-4ce3-a0ca-d159562370b1	2026-08-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Isotretinoin generic name: ISOTRETINOIN
Isotretinoin	ISOTRETINOIN	Actavis Pharma, Inc.	1cf11710-f966-4529-8e08-02175f588bca	2026-08-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Isotretinoin generic name: ISOTRETINOIN
Absorica LD	ISOTRETINOIN	Sun Pharmaceutical Industries, Inc.	3ef0cff8-19c1-4441-b780-fca6c7ee1615	2026-08-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ISOTRETINOIN
Amnesteem	ISOTRETINOIN	Mylan Pharmaceuticals Inc.	b2cb63c9-f825-4991-9a2c-6260f1bbcc2c	2026-08-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ISOTRETINOIN
Claravis	ISOTRETINOIN	Teva Pharmaceuticals USA, Inc.	a31fd109-d0fd-4ab9-ba98-a3d64333c18d	2026-07-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ISOTRETINOIN
Isotretinoin	ISOTRETINOIN	Zydus Pharmaceuticals USA Inc.	28948c32-a598-4bb5-bdb5-efbd87214d98	2026-07-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Isotretinoin generic name: ISOTRETINOIN
ZENATANE	ISOTRETINOIN	BluePoint Laboratories	486d4a4b-0de5-431a-bef7-dae6b0e4fa20	2026-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ISOTRETINOIN
Isotretinoin	ISOTRETINOIN	Upsher-Smith Laboratories, LLC	08529687-26b2-41e5-b6fb-35b4c0d891fe	2026-02-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Isotretinoin generic name: ISOTRETINOIN
Isotretinoin	ISOTRETINOIN	Upsher-Smith Laboratories, LLC	c369e1c3-90c5-4768-9741-56c62253a2c4	2026-02-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Isotretinoin generic name: ISOTRETINOIN
ACCUTANE	ISOTRETINOIN	JG Pharma Inc.	5b524a51-a16b-496e-b764-11c98c479c36	2026-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ISOTRETINOIN
Isotretinoin	ISOTRETINOIN	Zydus Lifesciences Limited	245898e5-3a61-4d6a-8375-8b3a8b7364ac	2025-06-04		Name fallback brand name: Isotretinoin generic name: ISOTRETINOIN
Isotretinoin	ISOTRETINOIN	Zydus Lifesciences Limited	dae33df0-386c-4db5-9759-7096e770ed17	2024-11-30		Name fallback brand name: Isotretinoin generic name: ISOTRETINOIN
Isotretinoin	ISOTRETINOIN	Mayne Pharma	0114567b-3bac-490d-b9eb-03a6c5d90935	2024-06-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Isotretinoin generic name: ISOTRETINOIN
Isotretinoin	ISOTRETINOIN	Sun Pharmaceutical Industries, Inc.	b44200ba-6672-4ea7-b151-7caec3f53c9c	2024-01-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Isotretinoin generic name: ISOTRETINOIN
Isotretinoin	ISOTRETINOIN	Amneal Pharmaceuticals NY LLC	9f1c8971-c6dc-4708-848b-5cee50b6c32a	2023-08-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Isotretinoin generic name: ISOTRETINOIN
Isotretinoin	ISOTRETINOIN	Mayne Pharma	72867c88-070f-4608-bfef-cc5225ebce6d	2022-11-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Isotretinoin generic name: ISOTRETINOIN
Isotretinoin	ISOTRETINOIN	Mayne Pharma	ebe1b3e3-1013-4cf6-bdc8-2baa3dc26e16	2022-11-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Isotretinoin generic name: ISOTRETINOIN
Isotretinoin	ISOTRETINOIN	Upsher-Smith Laboratories, LLC	ff1edbb8-ac0e-4563-9c2a-94385ce055e3	2022-10-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Isotretinoin generic name: ISOTRETINOIN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.