Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 201463
Company: LANNETT CO INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DRONABINOL DRONABINOL 2.5MG CAPSULE;ORAL Prescription AB No No
DRONABINOL DRONABINOL 5MG CAPSULE;ORAL Prescription AB No No
DRONABINOL DRONABINOL 10MG CAPSULE;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/18/2018 ORIG-1 Approval Not Applicable

Label is not available on this site.

DRONABINOL

CAPSULE;ORAL; 2.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DRONABINOL DRONABINOL 2.5MG CAPSULE;ORAL Prescription No AB 079217 AKORN INC
DRONABINOL DRONABINOL 2.5MG CAPSULE;ORAL Prescription No AB 201463 LANNETT CO INC
DRONABINOL DRONABINOL 2.5MG CAPSULE;ORAL Prescription No AB 078292 SVC PHARMA
MARINOL DRONABINOL 2.5MG CAPSULE;ORAL Prescription Yes AB 018651 ABBVIE

CAPSULE;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DRONABINOL DRONABINOL 5MG CAPSULE;ORAL Prescription No AB 079217 AKORN INC
DRONABINOL DRONABINOL 5MG CAPSULE;ORAL Prescription No AB 201463 LANNETT CO INC
DRONABINOL DRONABINOL 5MG CAPSULE;ORAL Prescription No AB 078292 SVC PHARMA
MARINOL DRONABINOL 5MG CAPSULE;ORAL Prescription Yes AB 018651 ABBVIE

CAPSULE;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DRONABINOL DRONABINOL 10MG CAPSULE;ORAL Prescription No AB 079217 AKORN INC
DRONABINOL DRONABINOL 10MG CAPSULE;ORAL Prescription No AB 201463 LANNETT CO INC
DRONABINOL DRONABINOL 10MG CAPSULE;ORAL Prescription No AB 078292 SVC PHARMA
MARINOL DRONABINOL 10MG CAPSULE;ORAL Prescription Yes AB 018651 ABBVIE

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