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Details for New Drug Application (NDA): 021951

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

The generic ingredient in ABSORICA is isotretinoin. There are eleven 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 NDA: 021951

Tradename:
ABSORICA
Applicant:
Ranbaxy
Ingredient:
isotretinoin
Patents:5
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 021951

Ingredient-typeRetinoids

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 Ranbaxy Laboratories 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 Ranbaxy Laboratories Inc. 10631-116 10631-116-31 3 BLISTER PACK in 1 BOX (10631-116-31) > 10 CAPSULE in 1 BLISTER PACK (10631-116-69)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:May 25, 2012TE:BXRLD:No
Patent:7,435,427Patent Expiration:Sep 21, 2021Product Flag?YSubstance Flag?Delist Request?
Patent:8,952,064Patent Expiration:Sep 21, 2021Product Flag?YSubstance Flag?Delist Request?
Patent:9,078,925Patent Expiration:Sep 21, 2021Product Flag?YSubstance Flag?Delist Request?


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