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ASCOR

NDA

ASCORBIC ACID | N209112 | MCGUFF PHARMACEUTICALS INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

7 petitions (7 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Maiva Pharma Private Limited FDA-2024-P-4461 Maiva Pharma Private Limited submitted this citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval of a suitability petition to allow submission of an ANDA for Ascorbic Acid Injection, USP in single-dose vial strengths of 50 mg/2 mL, 100 mg/4	Suitability	2024-09-23	Open	Maiva Pharma Private Limited
Exhibit 2 - Proposed Package Insert for Ascorbic Acid Injection, USP, 2,500 m... FDA-2022-P-0979 ArentFox Schiff LLP filed a citizen petition regarding ascorbic acid injection in various concentrations (2,500 mg/5 mL, 5,000 mg/10 mL, and 25,000 mg/50 mL vials), requesting FDA suitability determination for the proposed package insert labeling for these injectable ascorbic acid products.	Suitability	2022-06-06	Open	ArentFox Schiff LLP
Suitability Petition from ArentFox Schiff LLP FDA-2022-P-0979 ArentFox Schiff LLP filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Ascorbic Acid Injection, USP in 2,500 mg/5 mL and 5,000 mg/10 mL presentations (500 mg/mL concentration) suitable for submission in an ANDA, with	Suitability	2022-06-06	Open	ArentFox Schiff LLP
Exhibit 1 - Package Insert for McGuff Pharmaceuticals Inc.’s ASCOR (Ascorbic ... FDA-2022-P-0979 ArentFox Schiff LLP filed a suitability petition regarding McGuff Pharmaceuticals Inc.'s ASCOR (Ascorbic Acid Injection, approved under NDA 209112 on October 2, 2017). The petition references the product's package insert and label as part of a suitability determination request.	Suitability	2022-06-06	Open	ArentFox Schiff LLP
Suitability Petition from BPI Labs, LLC FDA-2021-P-0345 BPI Labs, LLC submitted this suitability petition under Section 505(j)(2)(C) of the FD&C Act requesting FDA approval to file an Abbreviated New Drug Application for Ascorbic Acid Injection 5000 mg/10 mL (500 mg/mL), which differs from the reference listed drug ASCOR (NDA 209112) only in fill volume,	Suitability	2021-04-01	Open	BPI Labs
Attachment 2 - Highlights of Prescribing Information for Ascor RE Suitability... FDA-2021-P-0345 BPI Labs, LLC filed a citizen petition regarding Ascor RE, requesting that the FDA determine the suitability of the product's prescribing information. The petition seeks FDA review and approval of the proposed highlights of prescribing information for this pharmaceutical product.	Suitability	2021-04-01	Open	BPI Labs
Attachment 3 - Highlights of Prescribing Information for Ascorbic acid inject... FDA-2021-P-0345 BPI Labs, LLC filed a suitability petition regarding ascorbic acid injection, which appears to involve a request for regulatory approval or recognition of the drug product's suitability for marketing as an NDA or ANDA. The attachment provided contains only prescribing information highlights and does	Suitability	2021-04-01	Open	BPI Labs

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

6 trials from ClinicalTrials.gov — 5 recruiting, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Link Between ASCorbemia Level and Osteoporosis NCT07660484	N/A	Not Yet Recruiting	Centre Hospitalier Universitaire de Nice	40	2026-07-01 → 2028-01-01
To Assess Dose Proportionality and Pharmacokinetic Linearity of Saninova Tablets in Healthy Participants Under Fasting Conditions NCT07664657	N/A	Not Yet Recruiting	Sichuan Credit Pharmaceutical Co., Ltd.	32	2026-06 → 2026-07
Effect of Co-enzyme Q10 and Vitamin C Alone or in Combination After a Surgical Gingival Depigmentation NCT07677826	N/A	Recruiting	Al-Azhar University	20	2026-03-02 → 2026-12-20
Perioperative Vitamin C to Reduce Persistent Pain After Total Knee Arthroplasty NCT06123715	Phase 2	Recruiting	University Health Network, Toronto	400	2024-04-16 → 2027-12-31
Developing a Nutritional Supplement to Increase Collagen Synthesis in People NCT06138106	N/A	Recruiting	University of California, Davis	20	2023-11-21 → 2026-12-01
The Body's Affect on Vitamin C NCT00001309	Phase 1	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	23	1997-01-23 → 2019-03-04

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain4 active DMFs1 inactive

4 active API suppliers hold Drug Master Files for this ingredient.

CSPC WEISHENG PHARMACEUTICAL SHIJIAZHUANG CO LTDASCORBIC ACID (VITAMIN C)

DMF 231622009

AMOLI ORGANICS PVT LTDASCORBIC ACID USP

DMF 265962012

DSM-FIRMENICH SWITZERLAND AGASCORBIC ACID

DMF 306182016

SHANDONG TIANLI PHARMACEUTICAL CO LTDASCORBIC ACID

DMF 387172024

BASF HEALTH AND NUTRITION ASInactiveASCORBIC ACID

DMF 43721981

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Jan 25, 2024	SUPPL -9	View Letter (PDF)
Jul 11, 2022	SUPPL -7	View Letter (PDF)
Oct 4, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 25,000MG/50ML (500MG/ML)

RLDAP

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Oct 2, 2017

No patent or exclusivity listings for this strength.