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

NDC Listings For This Application#

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

Application 211913

Related Records#

Application Products#

NDC Listings For This Application#

Documents#