ATORVASTATIN CALCIUM | N213260 | CMP DEVELOPMENT 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 | Granted | Newcastle Bioscience, LLC |
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 | Granted | Newcastle Bioscience, LLC |
Citizen Petition from Lachman Consultant Services Inc FDA-2017-P-2967 Lachman Consultant Services Inc filed this petition on behalf of a client requesting that the FDA declare Atorvastatin Calcium Orally Disintegrating Tablets in strengths of 10 mg, 20 mg, 40 mg, and 80 mg suitable for submission as an ANDA, with the reference-listed drug being Lipitor tablets approve | Other | 2017-05-11 | Granted | Lachman Consultant Services Inc |
Citizen Petition from Lachman Consultant Services, Inc. FDA-2004-P-0023 Lachman Consultant Services, Inc. filed this petition under Section 505(j)(2)(C) requesting that the FDA determine Atorvastatin Calcium Capsules in 10 mg, 20 mg, 40 mg, and 80 mg strengths are suitable for submission in an ANDA, with Lipitor (atorvastatin calcium) Tablets 80 mg as the reference-list | Other | 2014-08-17 | Open | Lachman Consultant Services, Inc. |
Citizen Petition Withdrawal Letter from Lachman Consultant Services, Inc. to ... FDA-2004-P-0023 Lachman Consultant Services, Inc. submitted a citizen petition on September 13, 2004 under Section 505(b)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Atorvastatin Calcium Capsules in strengths of 10 mg, 20 mg, 40 mg, and 80 mg suitable for submission in an abbrev | Other | 2014-08-17 | Open | — |
Citizen Petition from Pharmacists Planning Service Inc FDA-2014-P-0496 Pharmacists Planning Service Inc. filed this citizen petition under 21 CFR 10.20 and 10.30 requesting that the FDA Commissioner issue a Federal Regulation to reclassify Lipitor/Atorvastatin Calcium 10 mg to allow it to be sold in both prescription and pharmacist-supervised behind-the-counter categor | Other | 2014-05-05 | Denied | Pharmacists Planning Service Inc |
Lupin Pharmaceuticals, Inc - ANDA Suitability Citizen Petition [FDA-2008-P-00... FDA-2008-P-0085 Lupin Pharmaceuticals, Inc. filed this citizen petition on February 1, 2008, pursuant to 21 CFR 314.93 and Section 505(j)(2)(c) of the Federal Food, Drug and Cosmetic Act, requesting that the FDA declare Atorvastatin Calcium Capsules in 10 mg, 20 mg, 40 mg, and 80 mg strengths suitable for submissio | Suitability | 2008-02-07 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$1.23
per ml
Lowest NADAC/Unit
$1.23
per ml
Brand NDCs
1
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 46287003001ATORVALIQ 20 MG/5 ML SUSP | $1.23 | ML | Brand | — | 2026-10-01 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.