Application 211913

Type: NDA
Sponsor: SUN PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ABSORICA LD	ISOTRETINOIN	CAPSULE;ORAL	8MG	Yes	No
002	ABSORICA LD	ISOTRETINOIN	CAPSULE;ORAL	16MG	Yes	No
003	ABSORICA LD	ISOTRETINOIN	CAPSULE;ORAL	20MG	Yes	No
004	ABSORICA LD	ISOTRETINOIN	CAPSULE;ORAL	24MG	Yes	No
005	ABSORICA LD	ISOTRETINOIN	CAPSULE;ORAL	28MG	Yes	No
006	ABSORICA LD	ISOTRETINOIN	CAPSULE;ORAL	32MG	Yes	Yes

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	RLD / RS	Approval date
N211913-001	ABSORICA LD	ISOTRETINOIN	8MG	CAPSULE / ORAL	RLD	2019-11-05
N211913-002	ABSORICA LD	ISOTRETINOIN	16MG	CAPSULE / ORAL	RLD	2019-11-05
N211913-003	ABSORICA LD	ISOTRETINOIN	20MG	CAPSULE / ORAL	RLD	2019-11-05
N211913-004	ABSORICA LD	ISOTRETINOIN	24MG	CAPSULE / ORAL	RLD	2019-11-05
N211913-005	ABSORICA LD	ISOTRETINOIN	28MG	CAPSULE / ORAL	RLD	2019-11-05
N211913-006	ABSORICA LD	ISOTRETINOIN	32MG	CAPSULE / ORAL	RLD, RS	2019-11-05

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N211913-001	9750711	2035-05-29	Drug product	2019-11-25
N211913-001	9700535	2035-08-04	Drug product	2019-11-25
N211913-002	9750711	2035-05-29	Drug product	2019-11-25
N211913-002	9700535	2035-08-04	Drug product	2019-11-25
N211913-003	9750711	2035-05-29	Drug product	2019-11-25
N211913-003	9700535	2035-08-04	Drug product	2019-11-25
N211913-004	9750711	2035-05-29	Drug product	2019-11-25
N211913-004	9700535	2035-08-04	Drug product	2019-11-25
N211913-005	9750711	2035-05-29	Drug product	2019-11-25
N211913-005	9700535	2035-08-04	Drug product	2019-11-25
N211913-006	9750711	2035-05-29	Drug product	2019-11-25
N211913-006	9700535	2035-08-04	Drug product	2019-11-25

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 · 228 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N211913-001	ABSORICA LD	8MG	CAPSULE / ORAL	RLD	2019-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211913-002	ABSORICA LD	16MG	CAPSULE / ORAL	RLD	2019-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211913-003	ABSORICA LD	20MG	CAPSULE / ORAL	RLD	2019-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211913-004	ABSORICA LD	24MG	CAPSULE / ORAL	RLD	2019-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211913-005	ABSORICA LD	28MG	CAPSULE / ORAL	RLD	2019-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211913-006	ABSORICA LD	32MG	CAPSULE / ORAL	RLD, RS	2019-11-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211913-001	ABSORICA LD	8MG	CAPSULE / ORAL	RLD	2019-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211913-002	ABSORICA LD	16MG	CAPSULE / ORAL	RLD	2019-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211913-003	ABSORICA LD	20MG	CAPSULE / ORAL	RLD	2019-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211913-004	ABSORICA LD	24MG	CAPSULE / ORAL	RLD	2019-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211913-005	ABSORICA LD	28MG	CAPSULE / ORAL	RLD	2019-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211913-006	ABSORICA LD	32MG	CAPSULE / ORAL	RLD, RS	2019-11-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211913-001	ABSORICA LD	8MG	CAPSULE / ORAL	RLD	2019-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211913-002	ABSORICA LD	16MG	CAPSULE / ORAL	RLD	2019-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211913-003	ABSORICA LD	20MG	CAPSULE / ORAL	RLD	2019-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211913-004	ABSORICA LD	24MG	CAPSULE / ORAL	RLD	2019-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211913-005	ABSORICA LD	28MG	CAPSULE / ORAL	RLD	2019-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211913-006	ABSORICA LD	32MG	CAPSULE / ORAL	RLD, RS	2019-11-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211913-001	ABSORICA LD	8MG	CAPSULE / ORAL	RLD	2019-11-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211913-002	ABSORICA LD	16MG	CAPSULE / ORAL	RLD	2019-11-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211913-003	ABSORICA LD	20MG	CAPSULE / ORAL	RLD	2019-11-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211913-004	ABSORICA LD	24MG	CAPSULE / ORAL	RLD	2019-11-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211913-005	ABSORICA LD	28MG	CAPSULE / ORAL	RLD	2019-11-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211913-006	ABSORICA LD	32MG	CAPSULE / ORAL	RLD, RS	2019-11-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211913-001	ABSORICA LD	8MG	CAPSULE / ORAL	RLD	2019-11-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211913-002	ABSORICA LD	16MG	CAPSULE / ORAL	RLD	2019-11-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211913-003	ABSORICA LD	20MG	CAPSULE / ORAL	RLD	2019-11-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211913-004	ABSORICA LD	24MG	CAPSULE / ORAL	RLD	2019-11-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211913-005	ABSORICA LD	28MG	CAPSULE / ORAL	RLD	2019-11-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211913-006	ABSORICA LD	32MG	CAPSULE / ORAL	RLD, RS	2019-11-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211913-001	ABSORICA LD	8MG	CAPSULE / ORAL	RLD	2019-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211913-002	ABSORICA LD	16MG	CAPSULE / ORAL	RLD	2019-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211913-003	ABSORICA LD	20MG	CAPSULE / ORAL	RLD	2019-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211913-004	ABSORICA LD	24MG	CAPSULE / ORAL	RLD	2019-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211913-005	ABSORICA LD	28MG	CAPSULE / ORAL	RLD	2019-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211913-006	ABSORICA LD	32MG	CAPSULE / ORAL	RLD, RS	2019-11-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211913-001	ABSORICA LD	8MG	CAPSULE / ORAL	RLD	2019-11-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211913-002	ABSORICA LD	16MG	CAPSULE / ORAL	RLD	2019-11-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211913-003	ABSORICA LD	20MG	CAPSULE / ORAL	RLD	2019-11-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211913-004	ABSORICA LD	24MG	CAPSULE / ORAL	RLD	2019-11-05	`2680178bc6a6…`

Observed Orange Book patent history#

Patent history page 1 of 12 · 456 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N211913-001	9750711	2035-05-29	Drug product	2019-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211913-001	9700535	2035-08-04	Drug product	2019-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211913-002	9750711	2035-05-29	Drug product	2019-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211913-002	9700535	2035-08-04	Drug product	2019-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211913-003	9750711	2035-05-29	Drug product	2019-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211913-003	9700535	2035-08-04	Drug product	2019-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211913-004	9750711	2035-05-29	Drug product	2019-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211913-004	9700535	2035-08-04	Drug product	2019-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211913-005	9750711	2035-05-29	Drug product	2019-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211913-005	9700535	2035-08-04	Drug product	2019-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211913-006	9750711	2035-05-29	Drug product	2019-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211913-006	9700535	2035-08-04	Drug product	2019-11-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211913-001	9750711	2035-05-29	Drug product	2019-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211913-001	9700535	2035-08-04	Drug product	2019-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211913-002	9750711	2035-05-29	Drug product	2019-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211913-002	9700535	2035-08-04	Drug product	2019-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211913-003	9750711	2035-05-29	Drug product	2019-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211913-003	9700535	2035-08-04	Drug product	2019-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211913-004	9750711	2035-05-29	Drug product	2019-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211913-004	9700535	2035-08-04	Drug product	2019-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211913-005	9750711	2035-05-29	Drug product	2019-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211913-005	9700535	2035-08-04	Drug product	2019-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211913-006	9750711	2035-05-29	Drug product	2019-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211913-006	9700535	2035-08-04	Drug product	2019-11-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211913-001	9750711	2035-05-29	Drug product	2019-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211913-001	9700535	2035-08-04	Drug product	2019-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211913-002	9750711	2035-05-29	Drug product	2019-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211913-002	9700535	2035-08-04	Drug product	2019-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211913-003	9750711	2035-05-29	Drug product	2019-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211913-003	9700535	2035-08-04	Drug product	2019-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211913-004	9750711	2035-05-29	Drug product	2019-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211913-004	9700535	2035-08-04	Drug product	2019-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211913-005	9750711	2035-05-29	Drug product	2019-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211913-005	9700535	2035-08-04	Drug product	2019-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211913-006	9750711	2035-05-29	Drug product	2019-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211913-006	9700535	2035-08-04	Drug product	2019-11-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211913-001	9750711	2035-05-29	Drug product	2019-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211913-001	9700535	2035-08-04	Drug product	2019-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211913-002	9750711	2035-05-29	Drug product	2019-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211913-002	9700535	2035-08-04	Drug product	2019-11-25	`fd3edfee7708…`

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
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): 211913 application number: NDA211913 ndc (product): 10631-007 ndc (product): 10631-004 ndc (product): 10631-002 ndc (product): 10631-005 ndc (product): 10631-003 ndc (product): 10631-006

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10631-002	Absorica LD	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-002	Absorica LD	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-002	Absorica LD	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-002	Absorica LD	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-002	Absorica LD	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-002	Absorica LD	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-003	Absorica LD	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-003	Absorica LD	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-003	Absorica LD	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-003	Absorica LD	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-003	Absorica LD	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-003	Absorica LD	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-004	Absorica LD	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-004	Absorica LD	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-005	Absorica LD	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-005	Absorica LD	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-005	Absorica LD	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-005	Absorica LD	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-005	Absorica LD	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-005	Absorica LD	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-006	Absorica LD	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-006	Absorica LD	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-007	Absorica LD	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-007	Absorica LD	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-007	Absorica LD	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-007	Absorica LD	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-007	Absorica LD	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-007	Absorica LD	isotretinoin	Sun Pharmaceutical Industries, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84980	SUPPL	2026-02-10
76353	ORIG	2023-11-06
74840	SUPPL	2023-07-20
74790	SUPPL	2023-07-19
73876	SUPPL	2023-03-27
72269	SUPPL	2022-10-07
70765	SUPPL	2022-04-14
70733	SUPPL	2022-04-08
68971	SUPPL	2021-10-13
65565	SUPPL	2020-12-10
62148	ORIG	2020-03-16
60797	ORIG	2019-11-08
60793	ORIG	2019-11-08