ATORVASTATIN CALCIUM | A077575 | CHARTWELL RX SCIENCES LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 2 - Draft Insert Label for Atorvastatin Calcium Orally Disintegrat... FDA-2023-P-4281 Newcastle Bioscience, LLC filed a suitability petition regarding atorvastatin calcium orally disintegrating tablets, requesting FDA determination that the proposed drug product formulation and manufacturing process are suitable for approval under the abbreviated new drug application pathway. | Suitability | 2023-10-02 | Open | Newcastle Bioscience |
Attachment 3 - Approved labeling for reference-listed drug, Lipitor (atorvast... FDA-2023-P-4281 Newcastle Bioscience, LLC filed a citizen petition regarding the suitability of Lipitor (atorvastatin calcium) tablets as a reference-listed drug for purposes of generic drug applications. The petition likely requested FDA evaluation or confirmation of Lipitor's appropriateness as the reference stan | Suitability | 2023-10-02 | Open | Newcastle Bioscience |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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