Amphastar Pharmaceuticals, Inc.

Respond to the Complete Response Letter for Naloxone Intranasal

Deadline passed; outcome being checked

Announced: 12 Jan 2021
Due: 31 Dec 2021
Status: Checking

Deadline
Met
Late
Not met
Today

What the company said

“Naloxone Intranasal, NDA is pending, planned response to CRL in 2021”

SourceAmphastar Pharmaceuticals, Inc. Form 8-K press release, 2021-01-12
FilingSEC filing index
Deadline as statedin 2021
Deadline used31 Dec 2021, the last day of the stated period
TypeRegulatory
Permanent referenceKI-C-2021-AMPH-021934
Cite as https://keptindex.org/c/KI-C-2021-AMPH-021934/ — this address never changes.

What we found

The deadline has passed. We check for public evidence starting 30 days after the deadline, and repeat the check if nothing clear turns up.

Commitment DNA

The structured record of this commitment. Fields the company did not state are left blank rather than guessed.

Event type: Regulatory other
Indicative materiality: Medium rules
Action: Respond
Deliverable: Response to CRL for Naloxone Intranasal
Language: Expected (“expects”, “plans”)
In the company’s control: High
Specificity: High
Conditional: Yes
Depends on: Regulatory

Tell me what happens

This deadline has not been settled yet. We check 30 days after it passes. Get an email when we record the outcome.

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How this entry was checked

Commitment recordedThe company's words were matched word for word against the filing.
OutcomeNot yet assessed. Nothing is judged before the deadline.

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