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Last Updated: November 23, 2024

Details for New Drug Application (NDA): 211913


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NDA 211913 describes ABSORICA LD, which is a drug marketed by Sun Pharm and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the ABSORICA LD profile page.

The generic ingredient in ABSORICA LD 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 211913
Tradename:ABSORICA LD
Applicant:Sun Pharm
Ingredient:isotretinoin
Patents:2
Pharmacology for NDA: 211913
Medical Subject Heading (MeSH) Categories for 211913
Suppliers and Packaging for NDA: 211913
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ABSORICA LD isotretinoin CAPSULE;ORAL 211913 NDA Sun Pharmaceutical Industries, Inc. 10631-002 10631-002-31 3 BLISTER PACK in 1 BOX (10631-002-31) / 10 CAPSULE in 1 BLISTER PACK
ABSORICA LD isotretinoin CAPSULE;ORAL 211913 NDA Sun Pharmaceutical Industries, Inc. 10631-003 10631-003-31 3 BLISTER PACK in 1 BOX (10631-003-31) / 10 CAPSULE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength8MG
Approval Date:Nov 5, 2019TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Aug 4, 2035Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:May 29, 2035Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength16MG
Approval Date:Nov 5, 2019TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Aug 4, 2035Product Flag?YSubstance Flag?Delist Request?

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