Application 021951

Type: NDA
Sponsor: SUN PHARM INDS INC

Application Products#

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

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

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	RLD / RS	Approval date
N021951-001	ABSORICA	ISOTRETINOIN	10MG	CAPSULE / ORAL	AB2	RLD	2012-05-25
N021951-002	ABSORICA	ISOTRETINOIN	20MG	CAPSULE / ORAL	AB2	RLD	2012-05-25
N021951-003	ABSORICA	ISOTRETINOIN	30MG	CAPSULE / ORAL	AB2	RLD	2012-05-25
N021951-004	ABSORICA	ISOTRETINOIN	40MG	CAPSULE / ORAL	AB2	RLD, RS	2012-05-25
N021951-005	ABSORICA	ISOTRETINOIN	25MG	CAPSULE / ORAL	AB2	RLD	2014-08-15
N021951-006	ABSORICA	ISOTRETINOIN	35MG	CAPSULE / ORAL	AB2	RLD	2014-08-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021951-001	AB2
N021951-002	AB2
N021951-003	AB2
N021951-004	AB2
N021951-005	AB2
N021951-006	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 7 · 252 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	N021951-001	ABSORICA	10MG	CAPSULE / ORAL	AB2	RLD	2012-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021951-002	ABSORICA	20MG	CAPSULE / ORAL	AB2	RLD	2012-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021951-003	ABSORICA	30MG	CAPSULE / ORAL	AB2	RLD	2012-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021951-004	ABSORICA	40MG	CAPSULE / ORAL	AB2	RLD, RS	2012-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021951-005	ABSORICA	25MG	CAPSULE / ORAL	AB2	RLD	2014-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021951-006	ABSORICA	35MG	CAPSULE / ORAL	AB2	RLD	2014-08-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021951-001	ABSORICA	10MG	CAPSULE / ORAL	AB2	RLD	2012-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021951-002	ABSORICA	20MG	CAPSULE / ORAL	AB2	RLD	2012-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021951-003	ABSORICA	30MG	CAPSULE / ORAL	AB2	RLD	2012-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021951-004	ABSORICA	40MG	CAPSULE / ORAL	AB2	RLD, RS	2012-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021951-005	ABSORICA	25MG	CAPSULE / ORAL	AB2	RLD	2014-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021951-006	ABSORICA	35MG	CAPSULE / ORAL	AB2	RLD	2014-08-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021951-001	ABSORICA	10MG	CAPSULE / ORAL	AB2	RLD	2012-05-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021951-002	ABSORICA	20MG	CAPSULE / ORAL	AB2	RLD	2012-05-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021951-003	ABSORICA	30MG	CAPSULE / ORAL	AB2	RLD	2012-05-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021951-004	ABSORICA	40MG	CAPSULE / ORAL	AB2	RLD, RS	2012-05-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021951-005	ABSORICA	25MG	CAPSULE / ORAL	AB2	RLD	2014-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021951-006	ABSORICA	35MG	CAPSULE / ORAL	AB2	RLD	2014-08-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021951-001	ABSORICA	10MG	CAPSULE / ORAL	AB2	RLD	2012-05-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021951-002	ABSORICA	20MG	CAPSULE / ORAL	AB2	RLD	2012-05-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021951-003	ABSORICA	30MG	CAPSULE / ORAL	AB2	RLD	2012-05-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021951-004	ABSORICA	40MG	CAPSULE / ORAL	AB2	RLD, RS	2012-05-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021951-005	ABSORICA	25MG	CAPSULE / ORAL	AB2	RLD	2014-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021951-006	ABSORICA	35MG	CAPSULE / ORAL	AB2	RLD	2014-08-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021951-001	ABSORICA	10MG	CAPSULE / ORAL	AB2	RLD	2012-05-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021951-002	ABSORICA	20MG	CAPSULE / ORAL	AB2	RLD	2012-05-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021951-003	ABSORICA	30MG	CAPSULE / ORAL	AB2	RLD	2012-05-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021951-004	ABSORICA	40MG	CAPSULE / ORAL	AB2	RLD, RS	2012-05-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021951-005	ABSORICA	25MG	CAPSULE / ORAL	AB2	RLD	2014-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021951-006	ABSORICA	35MG	CAPSULE / ORAL	AB2	RLD	2014-08-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021951-001	ABSORICA	10MG	CAPSULE / ORAL	AB2	RLD	2012-05-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021951-002	ABSORICA	20MG	CAPSULE / ORAL	AB2	RLD	2012-05-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021951-003	ABSORICA	30MG	CAPSULE / ORAL	AB2	RLD	2012-05-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021951-004	ABSORICA	40MG	CAPSULE / ORAL	AB2	RLD, RS	2012-05-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021951-005	ABSORICA	25MG	CAPSULE / ORAL	AB2	RLD	2014-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021951-006	ABSORICA	35MG	CAPSULE / ORAL	AB2	RLD	2014-08-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021951-001	ABSORICA	10MG	CAPSULE / ORAL	AB2	RLD	2012-05-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021951-002	ABSORICA	20MG	CAPSULE / ORAL	AB2	RLD	2012-05-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021951-003	ABSORICA	30MG	CAPSULE / ORAL	AB2	RLD	2012-05-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021951-004	ABSORICA	40MG	CAPSULE / ORAL	AB2	RLD, RS	2012-05-25	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 238 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	N021951-001	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021951-002	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021951-003	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021951-004	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021951-005	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021951-006	AB2	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021951-001	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021951-002	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021951-003	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021951-004	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021951-005	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021951-006	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021951-001	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021951-002	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021951-003	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021951-004	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021951-005	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021951-006	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021951-001	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021951-002	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021951-003	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021951-004	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021951-005	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021951-006	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021951-001	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021951-002	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021951-003	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021951-004	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021951-005	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021951-006	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021951-001	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021951-002	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021951-003	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021951-004	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021951-005	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021951-006	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021951-001	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021951-002	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021951-003	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021951-004	AB2	1	`03ed91905a0d…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 270 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021951-001	7435427	2021-09-21		Drug product	2012-06-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021951-001	8367102	2021-09-21	U-1347		2013-02-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021951-001	8952064	2021-09-21		Drug product	2015-02-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021951-001	9078925	2021-09-21		Drug product	2015-07-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021951-001	9089534	2021-09-21		Drug product	2015-09-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021951-002	7435427	2021-09-21		Drug product	2012-06-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021951-002	8367102	2021-09-21	U-1347			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021951-002	8952064	2021-09-21		Drug product	2015-02-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021951-002	9078925	2021-09-21		Drug product	2015-07-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021951-002	9089534	2021-09-21		Drug product	2015-09-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021951-003	7435427	2021-09-21		Drug product	2012-06-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021951-003	8367102	2021-09-21	U-1347			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021951-003	8952064	2021-09-21		Drug product	2015-02-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021951-003	9078925	2021-09-21		Drug product	2015-07-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021951-003	9089534	2021-09-21		Drug product	2015-09-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021951-004	7435427	2021-09-21		Drug product	2012-06-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021951-004	8367102	2021-09-21	U-1347			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021951-004	8952064	2021-09-21		Drug product	2015-02-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021951-004	9078925	2021-09-21		Drug product	2015-07-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021951-004	9089534	2021-09-21		Drug product	2015-09-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021951-005	7435427	2021-09-21		Drug product	2015-04-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021951-005	8367102	2021-09-21	U-1347		2015-04-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021951-005	8952064	2021-09-21		Drug product	2015-02-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021951-005	9078925	2021-09-21		Drug product	2015-07-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021951-005	9089534	2021-09-21		Drug product	2015-09-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021951-006	7435427	2021-09-21		Drug product	2015-04-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021951-006	8367102	2021-09-21	U-1347		2015-04-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021951-006	8952064	2021-09-21		Drug product	2015-02-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021951-006	9078925	2021-09-21		Drug product	2015-07-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021951-006	9089534	2021-09-21		Drug product	2015-09-17	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N021951-001	7435427	2021-09-21		Drug product	2012-06-07	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021951-001	8367102	2021-09-21	U-1347		2013-02-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021951-001	8952064	2021-09-21		Drug product	2015-02-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021951-001	9078925	2021-09-21		Drug product	2015-07-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021951-001	9089534	2021-09-21		Drug product	2015-09-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021951-002	7435427	2021-09-21		Drug product	2012-06-07	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021951-002	8367102	2021-09-21	U-1347			`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021951-002	8952064	2021-09-21		Drug product	2015-02-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021951-002	9078925	2021-09-21		Drug product	2015-07-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021951-002	9089534	2021-09-21		Drug product	2015-09-17	`782e0a99824c…`

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
Absorica LD	ISOTRETINOIN	Sun Pharmaceutical Industries, Inc.	3ef0cff8-19c1-4441-b780-fca6c7ee1615	2026-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021951 application number: NDA021951 ndc (product): 10631-117 ndc (product): 10631-134 ndc (product): 10631-115 ndc (product): 10631-116 ndc (product): 10631-133 ndc (product): 10631-118
Isotretinoin	ISOTRETINOIN	Sun Pharmaceutical Industries, Inc.	b44200ba-6672-4ea7-b151-7caec3f53c9c	2024-01-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021951 application number: NDA021951 ndc (product): 57664-024 ndc (product): 57664-023 ndc (product): 57664-021 ndc (product): 57664-025 ndc (product): 57664-020 ndc (product): 57664-022

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 48 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10631-115	Absorica	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-115	Absorica	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-115	Absorica	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-115	Absorica	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-115	Absorica	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-115	Absorica	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-115	Absorica	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-116	Absorica	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-116	Absorica	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-116	Absorica	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-116	Absorica	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-116	Absorica	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-116	Absorica	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-116	Absorica	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-117	Absorica	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-117	Absorica	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-117	Absorica	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-117	Absorica	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-117	Absorica	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-117	Absorica	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-117	Absorica	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-118	Absorica	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-118	Absorica	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-118	Absorica	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-118	Absorica	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-118	Absorica	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-118	Absorica	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-118	Absorica	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-133	Absorica	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-133	Absorica	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-133	Absorica	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-133	Absorica	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-133	Absorica	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-133	Absorica	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-133	Absorica	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-134	Absorica	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-134	Absorica	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-134	Absorica	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-134	Absorica	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-134	Absorica	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-134	Absorica	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-134	Absorica	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
57664-020	Isotretinoin	Isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA AUTHORIZED GENERIC	Current
57664-021	Isotretinoin	Isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA AUTHORIZED GENERIC	Current
57664-022	Isotretinoin	Isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA AUTHORIZED GENERIC	Current
57664-023	Isotretinoin	Isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA AUTHORIZED GENERIC	Current
57664-024	Isotretinoin	Isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA AUTHORIZED GENERIC	Current
57664-025	Isotretinoin	Isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84978	SUPPL	2026-02-10
79278	SUPPL	2024-08-02
79294	SUPPL	2024-07-02
74839	SUPPL	2023-07-20
74789	SUPPL	2023-07-19
73875	SUPPL	2023-03-27
72271	SUPPL	2022-10-07
68974	SUPPL	2021-10-13
65567	SUPPL	2020-12-10
61700	SUPPL	2020-01-28
60836	SUPPL	2019-11-14
60834	SUPPL	2019-11-14
60811	SUPPL	2019-11-12
55624	SUPPL	2018-09-27
55471	SUPPL	2018-09-13
54015	SUPPL	2018-05-04
54003	SUPPL	2018-05-03
53806	SUPPL	2018-04-24
48779	SUPPL	2017-06-20
28912	SUPPL	2016-07-12
6532	SUPPL	2016-02-05
37942	SUPPL	2015-09-08
6531	SUPPL	2015-09-08
16635	SUPPL	2014-08-20
6530	SUPPL	2014-08-19
37941	SUPPL	2014-07-31
6529	SUPPL	2014-07-31
44488	ORIG	2013-06-21
42357	ORIG	2013-05-24
28911	ORIG	2012-05-30
16634	ORIG	2012-05-29