As prescribed in 11.204-91 insert the following provision:
NEW DRUG APPLICATIONS (APR 2008 MEDICAL) - DLAD
Offerors shall represent below information pertaining to FDA approval of New Drug Applications (NDA) or Abbreviated New Drug Applications (ANDA), when such approval is a prerequisite to marketing, and container/closure system information relative to product stability. (If additional space is needed, the required information may be provided in an attachment to the offer.)
(a) NDA/ANDA. Item ___________________________, FDA Approval File Number _______________________, Date of FDA approval _________________________. Item ___________________, FDA Approval File Number ___________________, Date of FDA approval _______________________________.
(b) CONTAINER/CLOSURE SYSTEM MATERIALS.
(1) CONTAINER (e.g., clear glass, amber glass, high or low density polyethylene, etc.)_________________________________________________________________ ______________________________________________________________.
(2) CONTAINER SEAL. Specify substance (e.g., waxed paper) which would contact the drug._______________________________________________________________ ____________________________________________________________.
(3) CONTAINER CLOSURE AND CLOSURE LINER. Specify cap type (e.g., metal, polypropylene, etc.), and the material used to line the closure (e.g., fiber liner, eflon liner, etc.)__________________________________________________________________ ________________________________________________________.
(End of Provision)
