See the DrugPatentWatch profile for procainamide
What is the FDA approval date for procainamide?
The FDA approval date for procainamide depends on the specific product (brand/formulation) and whether you mean the original new drug approval or a later approval for a reformulation. The only reliable way to give one exact “FDA approval date” is to match the date to a specific FDA-reviewed product label (for example, a particular NDA).
Which procainamide product are you asking about?
Procainamide is marketed in different forms, and FDA approval dates can differ across products and application types. If you share any of the following, the exact approval date can be identified precisely:
- Brand name (if any)
- Dosage form/strength (e.g., tablets vs. injection)
- NDA number or application type (if you have it)
How to find the approval date quickly (what to look for)
On FDA labeling and product databases, the “Approval Date” is typically listed in the drug’s approval/label details. You can verify it by searching the FDA database for the exact procainamide product you mean, then reading the label’s “Approval Date” field.
If you meant the original FDA approval (historical)
If you are asking for the earliest FDA approval of procainamide as a drug substance (not a specific manufacturer’s current product), that information is usually found in historical drug approval records, which also require knowing which approval record you want (initial approval vs. product-level approvals).
If you tell me the brand name or strength/form (or paste the NDA number), I can give the exact FDA approval date for that specific procainamide product.