Details for New Drug Application (NDA): 021951

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NDA 021951 describes ABSORICA, which is a drug marketed by Sun Pharm Inds Inc and Sun Pharm and is included in two NDAs. It is available from one supplier. There are two patents protecting this drug and five Paragraph IV challenges. Additional details are available on the ABSORICA profile page.

The generic ingredient in ABSORICA is isotretinoin. There are thirteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the isotretinoin profile page.

Summary for 021951

Tradename:	ABSORICA
Applicant:	Sun Pharm Inds Inc
Ingredient:	isotretinoin
Patents:	0

Pharmacology for NDA: 021951

Medical Subject Heading (MeSH) Categories for 021951

Dermatologic Agents
Teratogens

Suppliers and Packaging for NDA: 021951

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ABSORICA	isotretinoin	CAPSULE;ORAL	021951	NDA	Sun Pharmaceutical Industries, Inc.	10631-115	10631-115-31	3 BLISTER PACK in 1 BOX (10631-115-31) / 10 CAPSULE in 1 BLISTER PACK (10631-115-69)
ABSORICA	isotretinoin	CAPSULE;ORAL	021951	NDA	Sun Pharmaceutical Industries, Inc.	10631-116	10631-116-31	3 BLISTER PACK in 1 BOX (10631-116-31) / 10 CAPSULE in 1 BLISTER PACK (10631-116-69)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	10MG
Approval Date:	May 25, 2012	TE:	AB2	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	20MG
Approval Date:	May 25, 2012	TE:	AB2	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	30MG
Approval Date:	May 25, 2012	TE:	AB2	RLD:	Yes

Expired US Patents for NDA 021951

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sun Pharm Inds Inc	ABSORICA	isotretinoin	CAPSULE;ORAL	021951-003	May 25, 2012	9,078,925	⤷ Get Started Free
Sun Pharm Inds Inc	ABSORICA	isotretinoin	CAPSULE;ORAL	021951-003	May 25, 2012	8,367,102	⤷ Get Started Free
Sun Pharm Inds Inc	ABSORICA	isotretinoin	CAPSULE;ORAL	021951-002	May 25, 2012	8,367,102	⤷ Get Started Free
Sun Pharm Inds Inc	ABSORICA	isotretinoin	CAPSULE;ORAL	021951-006	Aug 15, 2014	7,435,427	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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