ANDA and NDA Buy & Sell

Abbreviated New Drug Applications (ANDAs) and New Drug Applications (NDAs) represent submissions to the FDA for the approval of generic and brand-name drugs, respectively. Here’s what is typically included in Active and Discontinued Dossiers for all dosage forms:

Active Dossiers

Active dossiers refer to those currently in use or under FDA approval for commercial manufacturing and distribution. These include:

1. Product Information:

• Drug name (brand or generic).
• Dosage form (e.g., tablet, capsule, injection, cream).
• Strength(s) of the product.

2. Regulatory Status:

• Application number (ANDA or NDA).
• Current approval status (e.g., approved or pending).
• Patent certification and exclusivity details.

Technical Details:

• Composition of the drug (active ingredients and excipients).
• Manufacturing process details.
• Quality control and batch testing reports.

Clinical Data:

• Bioequivalence (for ANDAs).
• Safety and efficacy studies (for NDAs).

Compliance Information:

• Good Manufacturing Practice (GMP) compliance certifications.
• Annual updates as required by the FDA.
• Discontinued Dossiers
• Discontinued dossiers are those for products that are no longer manufactured, marketed, or distributed. They include:

  Historical Data:

  • Last active approval status.
  • Documentation of discontinuation (e.g., voluntary withdrawal, FDA-requested withdrawal).

  Reasons for Discontinuation:

  • Market factors (e.g., low demand, competitive pressure).
  • Manufacturing challenges.
  • Regulatory issues or safety concerns.

  Record Retention:

  • Data retained for compliance purposes, including product composition and manufacturing details.
  • Adverse event reporting during the product’s market life.

  Reactivation Potential:

  • Status indicating whether the product can be reintroduced with additional FDA approval.
  • Dosage Forms Covered

  All dosage forms under ANDA and NDA dossiers include:

  • Oral (tablets, capsules, suspensions).
  • Parenteral (injections, infusions).
  • Topical (ointments, creams, gels).
  • Inhalation (aerosols, powders).
  • Transdermal patches.
  • Suppositories and rectal forms.

  If you’re looking for more detailed data regarding specific dossiers, these are often accessible through FDA’s public databases like the Orange Book or by consulting regulatory submissions.

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