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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078292
Company: SVC PHARMA

Products on ANDA 078292

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078292

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.

Therapeutic Equivalents for ANDA 078292

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	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	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	078292	SVC PHARMA
MARINOL	DRONABINOL	10MG	CAPSULE;ORAL	Prescription	Yes	AB	018651	ALKEM LABS LTD

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