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Pharmaceutical Intelligence

Live enriched data streamed directly from the FDA Open Database

LIVE CONNECTION

Recent FDA Drug Submissions & Approvals

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Approved

Ammonium Lactate (Ammonium Lactate)

Watson Labs Inc
App: ANDA076829Cream

Type

Orig

Priority

Standard

Status Date

Feb 7, 2006

Approved

Baclofen (Baclofen)

Pharmobedient
App: ANDA077121Tablet

Type

Orig

Priority

Standard

Status Date

Jul 29, 2005

Approved

Bensulfoid (Sulfur)

Poythress
App: NDA002918Powder

Type

Orig

Priority

Unknown

Status Date

Sep 17, 1940

Approved

Levofloxacin (Levofloxacin)

Natco Pharma
App: ANDA076276Tablet

Type

Suppl

Priority

Standard

Status Date

Apr 26, 2019

Approved

Naproxen Sodium (Naproxen Sodium)

Able
App: ANDA076544Tablet

Type

Orig

Priority

Standard

Status Date

Aug 22, 2003

Approved

Acetaminophen And Codeine Phosphate (Acetaminophen / Codeine Phosphate)

Roxane
App: ANDA084659Tablet

Type

Orig

Priority

Standard

Status Date

May 10, 1976

Approved

Chlorpheniramine Maleate (Chlorpheniramine Maleate)

Watson Labs
App: ANDA085139Tablet

Type

Suppl

Priority

Standard

Status Date

Jul 8, 1987

Approved

Phendimetrazine Tartrate (Phendimetrazine Tartrate)

Ivax Pharms
App: ANDA085611Tablet

Type

Orig

Priority

Standard

Status Date

May 11, 1977

Approved

Sulfamethoxazole (Sulfamethoxazole)

Watson Labs
App: ANDA086000Tablet

Type

Original

Priority

Standard

Status Date

Unknown Date

Approved

Cephulac (Lactulose)

Sanofi Aventis Us
App: NDA017657Solution

Type

Suppl

Priority

Priority

Status Date

Sep 18, 1987

Approved

Sumatriptan Succinate (Sumatriptan Succinate)

Teva Parenteral
App: ANDA078318Injectable

Type

Orig

Priority

Standard

Status Date

Jul 29, 2008

Approved

Cilostazol (Cilostazol)

Chartwell Rx
App: ANDA077722Tablet

Type

Orig

Priority

Standard

Status Date

Sep 24, 2012

Approved

Aripiprazole (Aripiprazole)

Barr Labs Inc
App: ANDA078612Tablet, Orally Disintegrating

Type

Orig

Priority

Standard

Status Date

Nov 29, 2012

Approved

Famotidine (Famotidine)

Alembic Pharms Ltd
App: ANDA078916Tablet

Type

Suppl

Priority

Standard

Status Date

May 11, 2020

Approved

Prilocaine Hydrochloride (Prilocaine Hydrochloride)

Septodont Inc
App: ANDA079235Injectable

Type

Suppl

Priority

Standard

Status Date

Nov 2, 2018

Approved

Cyanocobalamin (Cyanocobalamin)

Dr Reddys
App: ANDA080573Injectable

Type

Suppl

Priority

Standard

Status Date

Aug 6, 1986

Approved

Cycrin (Medroxyprogesterone Acetate)

Esi
App: ANDA081239Tablet

Type

Suppl

Priority

Standard

Status Date

Nov 28, 1997

Approved

Hydrochlorothiazide (Hydrochlorothiazide)

Alra
App: ANDA083554Tablet

Type

Suppl

Priority

Standard

Status Date

Jul 21, 1982

Approved

Folic Acid (Folic Acid)

Pharmeral
App: ANDA084158Tablet

Type

Orig

Priority

Standard

Status Date

May 8, 1974

Approved

Pramipexole Dihydrochloride (Pramipexole Dihydrochloride)

Torrent Pharms
App: ANDA090865Tablet

Type

Suppl

Priority

Standard

Status Date

Oct 13, 2016

Approved

Daypro (Oxaprozin)

Pfizer
App: NDA018841Tablet

Type

Suppl

Priority

Standard

Status Date

Jan 6, 1998

Approved

Topotecan Hydrochloride (Topotecan Hydrochloride)

Rising
App: ANDA091542Injectable

Type

Orig

Priority

Standard

Status Date

Aug 28, 2012

Approved

Prednisone (Prednisone)

Udl
App: ANDA087985Tablet

Type

Original

Priority

Standard

Status Date

Unknown Date

Approved

Lidocaine Hydrochloride Viscous (Lidocaine Hydrochloride)

Actavis Mid Atlantic
App: ANDA086578Solution

Type

Suppl

Priority

Standard

Status Date

Jun 3, 1991

Approved

Aminophylline (Aminophylline)

Abraxis Pharm
App: ANDA087200Injectable

Type

Original

Priority

Standard

Status Date

Unknown Date

Mastering Pharmaceutical Intelligence with Real-Time FDA Data

In the highly regulated and competitive landscape of drug development, having access to accurate and real-time pharmaceutical intelligence is not just an advantage—it is a necessity. The FDA Open Data endpoint is a crucial reservoir of public health data, providing an immediate look into the evolving drug pipeline, including new drug applications (NDAs), biologics license applications (BLAs), and generic drug approvals (ANDAs).

Our pharmaceutical intelligence dashboard continuously streams data directly from the FDA, offering regulatory affairs professionals and medical affairs teams unprecedented visibility into competitor submissions. By monitoring FDA approvals and designation dates natively, your team can proactively map out competitive landscapes, track breakthrough therapy designations, and assess the market entry timelines of critical therapeutics across various dosage forms and priority review pathways.

The difference between early intervention and late reaction often hinges on the speed of data acquisition. The CURA platform enriches raw regulatory data into structured, actionable insights. Rather than manually querying isolated databases to confirm drug status, dosage forms, or submission types, our live FDA integration serves this critical intelligence instantly. This empowers strategy teams to forecast generic entries, understand shifting FDA review priorities, and allocate resources efficiently toward novel clinical programs.

Whether you are evaluating a competitor's priority review status, anticipating the impact of a novel orphan drug designation, or tracking systemic shifts in FDA regulatory cadence, leveraging real-time pharma intelligence bridges the gap between raw compliance tracking and proactive market strategy. Ensure your commercial and clinical decisions are backed by the most current regulatory actions directly from the source.