An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 206304
Company: COREPHARMA

Products on ANDA 206304

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE	DEXTROAMPHETAMINE SACCHARATE;AMPHETAMINE ASPARTATE MONOHYDRATE;DEXTROAMPHETAMINE SULFATE;AMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE;ORAL	None (Tentative Approval)	None	No	No
DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE	DEXTROAMPHETAMINE SACCHARATE;AMPHETAMINE ASPARTATE MONOHYDRATE;DEXTROAMPHETAMINE SULFATE;AMPHETAMINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE;ORAL	None (Tentative Approval)	None	No	No
DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE	DEXTROAMPHETAMINE SACCHARATE;AMPHETAMINE ASPARTATE MONOHYDRATE;DEXTROAMPHETAMINE SULFATE;AMPHETAMINE SULFATE	15MG	CAPSULE, EXTENDED RELEASE;ORAL	None (Tentative Approval)	None	No	No
DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE	DEXTROAMPHETAMINE SACCHARATE;AMPHETAMINE ASPARTATE MONOHYDRATE;DEXTROAMPHETAMINE SULFATE;AMPHETAMINE SULFATE	20MG	CAPSULE, EXTENDED RELEASE;ORAL	None (Tentative Approval)	None	No	No
DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE	DEXTROAMPHETAMINE SACCHARATE;AMPHETAMINE ASPARTATE MONOHYDRATE;DEXTROAMPHETAMINE SULFATE;AMPHETAMINE SULFATE	25MG	CAPSULE, EXTENDED RELEASE;ORAL	None (Tentative Approval)	None	No	No
DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE	DEXTROAMPHETAMINE SACCHARATE;AMPHETAMINE ASPARTATE MONOHYDRATE;DEXTROAMPHETAMINE SULFATE;AMPHETAMINE SULFATE	30MG	CAPSULE, EXTENDED RELEASE;ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206304

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/15/2016	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.

Top