F. Hoffmann-La Roche RX
FDA Approved Drugs

F. Hoffmann-La Roche RX

FDA Approved Drugs Database

FDA approved drug product records including application numbers, product numbers, drug names, active ingredients, dosage forms, strengths, approval dates and regulatory status.

RX
  • Total Records 7
  • Latest Approval Date Aug 17, 2011
  • Data Source FDA
  • First Approval Date May 03, 1995
All
139
View
Unclassified
1
View
Discontinued
131
View
RX
7
View
Company Overview

Company

F. Hoffmann-La Roche RX

Country

Switzerland

Website

Visit Website

Email

rocheirna@gene.com

Social Profiles

Company Snapshot

F. Hoffmann-La Roche RX

Konzern-Hauptsitz Grenzacherstrasse 124 CH-4070 Basel

Switzerland

www.roche.com/ rocheirna@gene.com View on Map
FDA Approved Drug Records ( 7 records )
1995
03 May
RX Application: 50722

Drug Name

CELLCEPT

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1995-05-03

50722 / 1

Active Ingredient

MYCOPHENOLATE MOFETIL

Application Number

50722

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1995-05-03

Regulatory Status

RX

1997
19 Jun
RX Application: 50723

Drug Name

CELLCEPT

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1997-06-19

50723 / 1

Active Ingredient

MYCOPHENOLATE MOFETIL

Application Number

50723

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1997-06-19

Regulatory Status

RX

1998
12 Aug
RX Application: 50758

Drug Name

CELLCEPT

Product Number

1

Dosage Form

-

Strength

500MG/VIAL

Approval Date

1998-08-12

50758 / 1

Active Ingredient

MYCOPHENOLATE MOFETIL HYDROCHLORIDE

Application Number

50758

Product Number

1

Dosage Form

-

Strength

500MG/VIAL

Approval Date

1998-08-12

Regulatory Status

RX

1998
01 Oct
RX Application: 50759

Drug Name

CELLCEPT

Product Number

1

Dosage Form

-

Strength

200MG/ML

Approval Date

1998-10-01

50759 / 1

Active Ingredient

MYCOPHENOLATE MOFETIL

Application Number

50759

Product Number

1

Dosage Form

-

Strength

200MG/ML

Approval Date

1998-10-01

Regulatory Status

RX

1999
27 Oct
RX Application: 21087

Drug Name

TAMIFLU

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

1999-10-27

21087 / 1

Active Ingredient

OSELTAMIVIR PHOSPHATE

Application Number

21087

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

1999-10-27

Regulatory Status

RX

2011
21 Mar
RX Application: 21246

Drug Name

TAMIFLU

Product Number

2

Dosage Form

-

Strength

EQ 6MG BASE/ML

Approval Date

2011-03-21

21246 / 2

Active Ingredient

OSELTAMIVIR PHOSPHATE

Application Number

21246

Product Number

2

Dosage Form

-

Strength

EQ 6MG BASE/ML

Approval Date

2011-03-21

Regulatory Status

RX

2011
17 Aug
RX Application: 202429

Drug Name

ZELBORAF

Product Number

1

Dosage Form

-

Strength

240MG

Approval Date

2011-08-17

202429 / 1

Active Ingredient

VEMURAFENIB

Application Number

202429

Product Number

1

Dosage Form

-

Strength

240MG

Approval Date

2011-08-17

Regulatory Status

RX

Related Databases
  • FDA Inspections
    0 View
  • EDQM CEP
    7 View
  • KDMF
    0 View
  • Japan DMF
    0 View
  • Eudra GMP
    0 View
  • NDC Database
    0 View
  • FDA Approved Drugs Database
    139 View
  • Drug Prices in Switzerland
    0 View
Drug Status Breakdown
7 total
  • RX
Official Source

FDA approved drug data is based on publicly available U.S. Food and Drug Administration Orange Book information.

Visit FDA Orange Book
FDA Approved Drug Record Details Preview

Explore important FDA approved drug information available in the records above.

Drug Name

CELLCEPT

Application Number

50722

Product Number

1

Active Ingredient

MYCOPHENOLATE MOFETIL

Dosage Form

-

Strength

250MG

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

Structured Database

Searchable pharmaceutical data

Reliable Data

Organized FDA drug records

Create a New Buying Request

Fields marked with * are mandatory.

Please enter quantity.
Please select a unit.
Please select quality standard.
Please select request type.
Please provide product specifications.
Please enter additional details.
Please select shipping preference.
Notice: By submitting this buying request, the provided product details and requirements may be published publicly on our marketplace.
Login to Submit