Tolmar
FDA Approved Drugs
Tolmar
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 15
- Latest Approval Date May 01, 2020
- Data Source FDA
- First Approval Date Jan 23, 2002
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FDA Approved Drug Records ( 15 records )
Drug Name
ELIGARD KIT
Product Number
1
Dosage Form
-
Strength
7.5MG
Approval Date
2002-01-23
Active Ingredient
LEUPROLIDE ACETATE
Application Number
21343
Product Number
1
Dosage Form
-
Strength
7.5MG
Approval Date
2002-01-23
Regulatory Status
RX
Drug Name
ELIGARD KIT
Product Number
1
Dosage Form
-
Strength
22.5MG
Approval Date
2002-07-24
Active Ingredient
LEUPROLIDE ACETATE
Application Number
21379
Product Number
1
Dosage Form
-
Strength
22.5MG
Approval Date
2002-07-24
Regulatory Status
RX
Drug Name
ELIGARD KIT
Product Number
1
Dosage Form
-
Strength
30MG
Approval Date
2003-02-13
Active Ingredient
LEUPROLIDE ACETATE
Application Number
21488
Product Number
1
Dosage Form
-
Strength
30MG
Approval Date
2003-02-13
Regulatory Status
RX
Drug Name
ELIGARD KIT
Product Number
1
Dosage Form
-
Strength
45MG
Approval Date
2004-12-14
Active Ingredient
LEUPROLIDE ACETATE
Application Number
21731
Product Number
1
Dosage Form
-
Strength
45MG
Approval Date
2004-12-14
Regulatory Status
RX
Drug Name
FENSOLVI KIT
Product Number
1
Dosage Form
-
Strength
45MG
Approval Date
2020-05-01
Active Ingredient
LEUPROLIDE ACETATE
Application Number
213150
Product Number
1
Dosage Form
-
Strength
45MG
Approval Date
2020-05-01
Regulatory Status
RX
Drug Name
JATENZO
Product Number
1
Dosage Form
-
Strength
158MG
Approval Date
2019-03-27
Active Ingredient
TESTOSTERONE UNDECANOATE
Application Number
206089
Product Number
1
Dosage Form
-
Strength
158MG
Approval Date
2019-03-27
Regulatory Status
RX
Drug Name
JATENZO
Product Number
2
Dosage Form
-
Strength
198MG
Approval Date
2019-03-27
Active Ingredient
TESTOSTERONE UNDECANOATE
Application Number
206089
Product Number
2
Dosage Form
-
Strength
198MG
Approval Date
2019-03-27
Regulatory Status
RX
Drug Name
JATENZO
Product Number
3
Dosage Form
-
Strength
237MG
Approval Date
2019-03-27
Active Ingredient
TESTOSTERONE UNDECANOATE
Application Number
206089
Product Number
3
Dosage Form
-
Strength
237MG
Approval Date
2019-03-27
Regulatory Status
RX
Drug Name
LEVETIRACETAM
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
2009-01-15
Active Ingredient
LEVETIRACETAM
Application Number
79107
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
2009-01-15
Regulatory Status
Discontinued
Drug Name
PALIPERIDONE PALMITATE
Product Number
1
Dosage Form
-
Strength
39MG/0.25ML
Approval Date
-
Active Ingredient
PALIPERIDONE PALMITATE
Application Number
211995
Product Number
1
Dosage Form
-
Strength
39MG/0.25ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
PALIPERIDONE PALMITATE
Product Number
2
Dosage Form
-
Strength
78MG/0.5ML
Approval Date
-
Active Ingredient
PALIPERIDONE PALMITATE
Application Number
211995
Product Number
2
Dosage Form
-
Strength
78MG/0.5ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
PALIPERIDONE PALMITATE
Product Number
3
Dosage Form
-
Strength
117MG/0.75ML
Approval Date
-
Active Ingredient
PALIPERIDONE PALMITATE
Application Number
211995
Product Number
3
Dosage Form
-
Strength
117MG/0.75ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
PALIPERIDONE PALMITATE
Product Number
4
Dosage Form
-
Strength
156MG/ML
Approval Date
-
Active Ingredient
PALIPERIDONE PALMITATE
Application Number
211995
Product Number
4
Dosage Form
-
Strength
156MG/ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
PALIPERIDONE PALMITATE
Product Number
5
Dosage Form
-
Strength
234MG/1.5ML
Approval Date
-
Active Ingredient
PALIPERIDONE PALMITATE
Application Number
211995
Product Number
5
Dosage Form
-
Strength
234MG/1.5ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
RANITIDINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 15MG BASE/ML
Approval Date
2010-11-15
Active Ingredient
RANITIDINE HYDROCHLORIDE
Application Number
90054
Product Number
1
Dosage Form
-
Strength
EQ 15MG BASE/ML
Approval Date
2010-11-15
Regulatory Status
Discontinued
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Drug Status Breakdown
15 total- RX
- Discontinued
- Unclassified
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
ELIGARD KIT
Application Number
21343
Product Number
1
Active Ingredient
LEUPROLIDE ACETATE
Dosage Form
-
Strength
7.5MG
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