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Last Updated: May 28, 2024

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. Twelve 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 021951
Medical Subject Heading (MeSH) Categories for 021951
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:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:May 25, 2012TE:AB2RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength20MG
Approval Date:May 25, 2012TE:AB2RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength30MG
Approval Date:May 25, 2012TE:AB2RLD:Yes

Expired US Patents for NDA 021951

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sun Pharm Inds Inc ABSORICA isotretinoin CAPSULE;ORAL 021951-006 Aug 15, 2014 ⤷  Sign Up ⤷  Sign Up
Sun Pharm Inds Inc ABSORICA isotretinoin CAPSULE;ORAL 021951-004 May 25, 2012 ⤷  Sign Up ⤷  Sign Up
Sun Pharm Inds Inc ABSORICA isotretinoin CAPSULE;ORAL 021951-006 Aug 15, 2014 ⤷  Sign Up ⤷  Sign Up
Sun Pharm Inds Inc ABSORICA isotretinoin CAPSULE;ORAL 021951-005 Aug 15, 2014 ⤷  Sign Up ⤷  Sign Up
Sun Pharm Inds Inc ABSORICA isotretinoin CAPSULE;ORAL 021951-001 May 25, 2012 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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