Recordati
FDA Approved Drugs
Recordati
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.
- Total Records 21
- Latest Approval Date Aug 19, 2020
- Data Source FDA
- First Approval Date Jan 01, 1982
Company Overview
Social Profiles
Company Snapshot
Recordati
Via Matteo Civitali, 1 20148 Milan
Italy
www.recordati.com/en/ svil@recordati.it View on MapFDA Approved Drug Records ( 21 records )
Drug Name
CARBAGLU
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2010-03-18
Active Ingredient
CARGLUMIC ACID
Application Number
22562
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2010-03-18
Regulatory Status
RX
Drug Name
CHEMET
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
1991-01-30
Active Ingredient
SUCCIMER
Application Number
19998
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
1991-01-30
Regulatory Status
RX
Drug Name
COSMEGEN
Product Number
1
Dosage Form
-
Strength
0.5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
DACTINOMYCIN
Application Number
50682
Product Number
1
Dosage Form
-
Strength
0.5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CYSTADANE
Product Number
1
Dosage Form
-
Strength
1GM/SCOOPFUL
Approval Date
1996-10-25
Active Ingredient
BETAINE
Application Number
20576
Product Number
1
Dosage Form
-
Strength
1GM/SCOOPFUL
Approval Date
1996-10-25
Regulatory Status
RX
Drug Name
CYSTADROPS
Product Number
1
Dosage Form
-
Strength
EQ 0.37% BASE
Approval Date
2020-08-19
Active Ingredient
CYSTEAMINE HYDROCHLORIDE
Application Number
211302
Product Number
1
Dosage Form
-
Strength
EQ 0.37% BASE
Approval Date
2020-08-19
Regulatory Status
RX
Drug Name
INDOCIN
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1985-01-30
Active Ingredient
INDOMETHACIN SODIUM
Application Number
18878
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1985-01-30
Regulatory Status
Discontinued
Drug Name
ISTURISA
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2020-03-06
Active Ingredient
OSILODROSTAT PHOSPHATE
Application Number
212801
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2020-03-06
Regulatory Status
RX
Drug Name
ISTURISA
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2020-03-06
Active Ingredient
OSILODROSTAT PHOSPHATE
Application Number
212801
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2020-03-06
Regulatory Status
RX
Drug Name
ISTURISA
Product Number
3
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2020-03-06
Active Ingredient
OSILODROSTAT PHOSPHATE
Application Number
212801
Product Number
3
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2020-03-06
Regulatory Status
Discontinued
Drug Name
MUSTARGEN
Product Number
1
Dosage Form
-
Strength
10MG/VIAL
Approval Date
1982-01-01
Active Ingredient
MECHLORETHAMINE HYDROCHLORIDE
Application Number
6695
Product Number
1
Dosage Form
-
Strength
10MG/VIAL
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
NEOPROFEN
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE/2ML (EQ 10MG BASE/ML)
Approval Date
2006-04-13
Active Ingredient
IBUPROFEN LYSINE
Application Number
21903
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE/2ML (EQ 10MG BASE/ML)
Approval Date
2006-04-13
Regulatory Status
RX
Drug Name
PEGANONE
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
1982-01-01
Active Ingredient
ETHOTOIN
Application Number
10841
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PEGANONE
Product Number
3
Dosage Form
-
Strength
500MG
Approval Date
1982-01-01
Active Ingredient
ETHOTOIN
Application Number
10841
Product Number
3
Dosage Form
-
Strength
500MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
SIGNIFOR
Product Number
1
Dosage Form
-
Strength
EQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)
Approval Date
2012-12-14
Active Ingredient
PASIREOTIDE DIASPARTATE
Application Number
200677
Product Number
1
Dosage Form
-
Strength
EQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)
Approval Date
2012-12-14
Regulatory Status
RX
Drug Name
SIGNIFOR
Product Number
2
Dosage Form
-
Strength
EQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)
Approval Date
2012-12-14
Active Ingredient
PASIREOTIDE DIASPARTATE
Application Number
200677
Product Number
2
Dosage Form
-
Strength
EQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)
Approval Date
2012-12-14
Regulatory Status
RX
Drug Name
SIGNIFOR
Product Number
3
Dosage Form
-
Strength
EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)
Approval Date
2012-12-14
Active Ingredient
PASIREOTIDE DIASPARTATE
Application Number
200677
Product Number
3
Dosage Form
-
Strength
EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)
Approval Date
2012-12-14
Regulatory Status
RX
Drug Name
SIGNIFOR LAR KIT
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE/VIAL
Approval Date
2014-12-15
Active Ingredient
PASIREOTIDE PAMOATE
Application Number
203255
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE/VIAL
Approval Date
2014-12-15
Regulatory Status
RX
Drug Name
SIGNIFOR LAR KIT
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE/VIAL
Approval Date
2014-12-15
Active Ingredient
PASIREOTIDE PAMOATE
Application Number
203255
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE/VIAL
Approval Date
2014-12-15
Regulatory Status
RX
Drug Name
SIGNIFOR LAR KIT
Product Number
3
Dosage Form
-
Strength
EQ 60MG BASE/VIAL
Approval Date
2014-12-15
Active Ingredient
PASIREOTIDE PAMOATE
Application Number
203255
Product Number
3
Dosage Form
-
Strength
EQ 60MG BASE/VIAL
Approval Date
2014-12-15
Regulatory Status
RX
Drug Name
SIGNIFOR LAR KIT
Product Number
4
Dosage Form
-
Strength
EQ 10MG BASE/VIAL
Approval Date
2018-06-29
Active Ingredient
PASIREOTIDE PAMOATE
Application Number
203255
Product Number
4
Dosage Form
-
Strength
EQ 10MG BASE/VIAL
Approval Date
2018-06-29
Regulatory Status
RX
Drug Name
SIGNIFOR LAR KIT
Product Number
5
Dosage Form
-
Strength
EQ 30MG BASE/VIAL
Approval Date
2018-06-29
Active Ingredient
PASIREOTIDE PAMOATE
Application Number
203255
Product Number
5
Dosage Form
-
Strength
EQ 30MG BASE/VIAL
Approval Date
2018-06-29
Regulatory Status
RX
Drug Status Breakdown
21 total- RX
- Discontinued
Official Source
FDA approved drug data is based on publicly available U.S. Food and Drug Administration Orange Book information.
Visit FDA Orange BookFDA Approved Drug Record Details Preview
Explore important FDA approved drug information available in the records above.
Drug Name
CARBAGLU
Application Number
22562
Product Number
1
Active Ingredient
CARGLUMIC ACID
Dosage Form
-
Strength
200MG
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.