Company profile for Aucta Pharmaceuticals

Aucta Pharmaceuticals-PSE
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Aucta is a global brand that creates better products from proven molecules.

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About

Aucta Pharmaceuticals is an emerging drug product development company focusing on new branded 505(b)(2) products and technology platform-based niche generics. Aucta adopts a branded/generic hybrid model, generating both near-term product revenue and mid- to long-term investment return, aiming to become a significant specialty pharma player in the United States and China marketplace. We focus on developing enhanced products for patients with a therapeutic focus on CNS disorders, as well as Ophthalmics, and Inhalation therapies.

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CORPORATE CONTENT #SupplierSpotlight

    https://www.pharmacompass.com/pdf/party/content/aucta-pharmaceuticals-party-content-96522.pdf

    https://www.pharmacompass.com/pdf/party/content/aucta-pharmaceuticals-party-content-13729.pdf

NEWS #PharmaBuzz

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https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218380

FDA
03 Feb 2025
Aucta debuts generic Vimpat
Aucta debuts generic Vimpat

11 Mar 2024

// DRUG STORE NEWS

https://drugstorenews.com/aucta-debuts-generic-vimpat

DRUG STORE NEWS
11 Mar 2024

https://www.prnewswire.com/news-releases/aucta-pharmaceuticals-inc-aucta-pharmaceuticals-launches-motpoly-xr-lacosamide-extended-release-capsules-c-v-the-first-and-only-once-daily-formulation-of-lacosamide-302070783.html

PR NEWSWIRE
26 Feb 2024

https://www.prnewswire.com/news-releases/aucta-announced-fda-approval-of-a-generic-version-of-trileptaloxcarbazepine-oral-suspension-301694327.html#:~:text=PISCATAWAY%2C%20N.J.%2C%20Dec.,this%20product%20in%20early%202023.

PR NEWSWIRE
05 Dec 2022

https://www.prnewswire.com/news-releases/aucta-announces-fda-approval-of-a-generic-version-of-perforomist-formoterol-fumarate-inhalation-solution-301691187.html

PRNEWSWIRE
01 Dec 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215332

FDA
30 Nov 2022

FDA Orange Book

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01

Brand Name : ARFORMOTEROL TARTRAT...

Aucta Pharmaceuticals

Dosage Form : SOLUTION; INHALATION

Proprietary Name : ARFORMOTEROL TARTRATE

Dosage Strength : EQ 0.015MG BASE/2ML

Approval Date : 2025-02-03

Application Number : 218380

RX/OTC/DISCN : RX

RLD : No

TE Code : AN

Aucta Company Banner

02

Brand Name : DEFERASIROX

Aucta Pharmaceuticals

Dosage Form : GRANULE; ORAL

Proprietary Name : DEFERASIROX

Dosage Strength : 90MG

Approval Date : 2021-03-09

Application Number : 214559

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Aucta Company Banner

03

Brand Name : DEFERASIROX

Aucta Pharmaceuticals

Dosage Form : GRANULE; ORAL

Proprietary Name : DEFERASIROX

Dosage Strength : 180MG

Approval Date : 2021-03-09

Application Number : 214559

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Aucta Company Banner

04

Brand Name : DEFERASIROX

Aucta Pharmaceuticals

Dosage Form : GRANULE; ORAL

Proprietary Name : DEFERASIROX

Dosage Strength : 360MG

Approval Date : 2021-03-09

Application Number : 214559

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Aucta Company Banner

05

Brand Name : MOTPOLY XR

Aucta Pharmaceuticals

Dosage Form : CAPSULE, EXTENDED RELEASE; ORA...

Proprietary Name : MOTPOLY XR

Dosage Strength : 100MG

Approval Date : 2023-05-04

Application Number : 216185

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Aucta Company Banner

06

Brand Name : MOTPOLY XR

Aucta Pharmaceuticals

Dosage Form : CAPSULE, EXTENDED RELEASE; ORA...

Proprietary Name : MOTPOLY XR

Dosage Strength : 150MG

Approval Date : 2023-05-04

Application Number : 216185

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Aucta Company Banner

07

Brand Name : MOTPOLY XR

Aucta Pharmaceuticals

Dosage Form : CAPSULE, EXTENDED RELEASE; ORA...

Proprietary Name : MOTPOLY XR

Dosage Strength : 200MG

Approval Date : 2023-05-04

Application Number : 216185

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Aucta Company Banner

08

Brand Name : OXCARBAZEPINE

Aucta Pharmaceuticals

Dosage Form : SUSPENSION; ORAL

Proprietary Name : OXCARBAZEPINE

Dosage Strength : 300MG/5ML

Approval Date : 2022-11-30

Application Number : 215332

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Aucta Company Banner

09

Brand Name : VIGADRONE

Aucta Pharmaceuticals

Dosage Form : FOR SOLUTION; ORAL

Proprietary Name : VIGADRONE

Dosage Strength : 500MG/PACKET

Approval Date : 2018-06-21

Application Number : 210196

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

Aucta Company Banner

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