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Last Updated: July 3, 2020

DrugPatentWatch Database Preview

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 seven 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. Six 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:5
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)
Paragraph IV (Patent) Challenges for 021951
Tradename Dosage Ingredient NDA Submissiondate
ABSORICA CAPSULE;ORAL isotretinoin 021951 2016-05-16
ABSORICA CAPSULE;ORAL isotretinoin 021951 2015-11-25
ABSORICA CAPSULE;ORAL isotretinoin 021951 2013-06-20
ABSORICA CAPSULE;ORAL isotretinoin 021951 2013-06-19
ABSORICA CAPSULE;ORAL isotretinoin 021951 2013-01-07
ABSORICA CAPSULE;ORAL isotretinoin 021951 2012-12-31

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:May 25, 2012TE:BXRLD:Yes
Patent:  Start TrialPatent Expiration:Sep 21, 2021Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Sep 21, 2021Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF A SKIN DISORDER
Patent:  Start TrialPatent Expiration:Sep 21, 2021Product Flag?YSubstance Flag?Delist Request?

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