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

NDC Listings For This Application#

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

Application 021951

Related Records#

Application Products#

NDC Listings For This Application#

Documents#