Replies to post #21033 on Intellipharmaceutics International Inc. (IPCI)

[Talc Moan]

When was this letter? This is Great News!

[Samsa]

Fabius.....I actually think PAR could have started and launched as of Nov. 30 the letter states

Accordingly the ANDA is approved, effective on the date of this letter.

The 14 days you are referring too is just for them to submit a copy of the labeling which as they state "identical to labeling already approved" that section is here

As soon as possible, but no later than 14 days from the date of this letter, submit, using the FDA
automated drug registration and listing system (eLIST), the content of labeling [21 CFR
314.50(l)] in structured product labeling (SPL) format, as described at
http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
, that is identical in content to the approved labeling (including the package insert, and any patient
package insert and/or Medication Guide that may be required)

I personally don't see anything that holds them up from launching whenever they want