To find all Generic Approvals and Tentative Approvals, you can search Drugs@FDA, using the " Drug Approval Reports by Month " feature. We add new approvals and tentative approvals to Drugs@FDA Reports daily.
On the Drug Approval Reports page, select:
"Original Abbreviated New Drug Approvals (ANDAs) by Month" for Generic Approvals
"Tentative Approvals by Month" for Tentative Approvals
The quarterly List of Authorized Generic Drugs includes the drug trade name, the brand company manufacturer, and the date the authorized generic drug entered the market.
The Division of Bioequivalence has developed new data summary tables for the in-vitro data recommended for nasal spray products. This format provides completeness and consistency of the data that will result in a more efficient review of the data. ANDA applicants should complete these tables and send the completed tables along with the rest of the bioequivalence submission of their ANDA. Bioequivalence Summary Tables For Aqueous Nasal Spray Products [PDF - 1015KB]
ANDA Checklist for Completeness and Acceptability [ PDF ] Note: In Sections 3.2.S.2.1 and 3.2.P.3.1, it is critically important that the correct Name, Full Address and establishment contact information of the manufacturing or testing facility location be included (not the corporate address). Additionally, the correct FDA Establishment Identifier number (FEI) or Central File Number (CFN) for the exact facility must be included.
Inactive Ingredient Database The newly revised Inactive Ingredients Database provides information on inactive ingredients present in FDA-approved drug products. This information can be used by industry as an aid in developing drug products.
Bioequivalence Study Retention Samples . (1/12/2001) Regulations state that applicants shall retain reserve samples of the tested products administered to study subjects and release these samples to FDA upon request. The Agency may then analyze these retention samples to ensure that the BA/BE results upon which FDA bases approval of New Drug Applications (NDA) and Abbreviated New Drug Applications (ANDAs) are reliable.
FDA Letters to Industry This series of letters informs generic drug product manufacturers of policy and procedure developments with respect to the Drug Price Competition and Patent Term Restoration Act of 1984.
These petitions are submitted to FDA by drug companies seeking permission to file an abbreviated new drug application for a change from a listed drug in dosage form, strength, route of administration, or active ingredient in a combination product. If FDA determines that the drug is suitable for a generic product, the petition is approved, if it is not suitable, the petition is denied.
CDER FOIA Electronic Reading Room Links to information about advisory committees; clinical investigators; the Division of Drug Marketing, Advertising and Communications correspondence; drug approval packages; and warning letters