Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 211913

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ABSORICA LD (ISOTRETINOIN)
8MG
Marketing Status: Prescription
Active Ingredient: ISOTRETINOIN
Proprietary Name: ABSORICA LD
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 8MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N211913
Product Number: 001
Approval Date: Nov 5, 2019
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
ABSORICA LD (ISOTRETINOIN)
16MG
Marketing Status: Prescription
Active Ingredient: ISOTRETINOIN
Proprietary Name: ABSORICA LD
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 16MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N211913
Product Number: 002
Approval Date: Nov 5, 2019
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
ABSORICA LD (ISOTRETINOIN)
20MG
Marketing Status: Prescription
Active Ingredient: ISOTRETINOIN
Proprietary Name: ABSORICA LD
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N211913
Product Number: 003
Approval Date: Nov 5, 2019
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
ABSORICA LD (ISOTRETINOIN)
24MG
Marketing Status: Prescription
Active Ingredient: ISOTRETINOIN
Proprietary Name: ABSORICA LD
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 24MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N211913
Product Number: 004
Approval Date: Nov 5, 2019
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
ABSORICA LD (ISOTRETINOIN)
28MG
Marketing Status: Prescription
Active Ingredient: ISOTRETINOIN
Proprietary Name: ABSORICA LD
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 28MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N211913
Product Number: 005
Approval Date: Nov 5, 2019
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
ABSORICA LD (ISOTRETINOIN)
32MG
Marketing Status: Prescription
Active Ingredient: ISOTRETINOIN
Proprietary Name: ABSORICA LD
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 32MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N211913
Product Number: 006
Approval Date: Nov 5, 2019
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

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