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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078292
Company: SVC PHARMA
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
06/27/2008 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078292s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/31/2011 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

10/29/2010 SUPPL-2 Labeling

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 207421 ASCENT PHARMS INC
DRONABINOL DRONABINOL 2.5MG CAPSULE;ORAL Prescription No AB 079217 HIKMA
DRONABINOL DRONABINOL 2.5MG CAPSULE;ORAL Prescription No AB 078292 SVC PHARMA
MARINOL DRONABINOL 2.5MG CAPSULE;ORAL Prescription Yes AB 018651 ALKEM LABS LTD

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 207421 ASCENT PHARMS INC
DRONABINOL DRONABINOL 5MG CAPSULE;ORAL Prescription No AB 079217 HIKMA
DRONABINOL DRONABINOL 5MG CAPSULE;ORAL Prescription No AB 078292 SVC PHARMA
MARINOL DRONABINOL 5MG CAPSULE;ORAL Prescription Yes AB 018651 ALKEM LABS LTD

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 207421 ASCENT PHARMS INC
DRONABINOL DRONABINOL 10MG CAPSULE;ORAL Prescription No AB 079217 HIKMA
DRONABINOL DRONABINOL 10MG CAPSULE;ORAL Prescription No AB 078292 SVC PHARMA
MARINOL DRONABINOL 10MG CAPSULE;ORAL Prescription Yes AB 018651 ALKEM LABS LTD
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