BPI Labs
FDA Approved Drugs
BPI Labs
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 14
- Latest Approval Date Apr 30, 2026
- Data Source FDA
- First Approval Date Jul 29, 2014
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FDA Approved Drug Records ( 14 records )
Drug Name
ABLYSINOL
Product Number
1
Dosage Form
-
Strength
99% (1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2018-06-21
Active Ingredient
DEHYDRATED ALCOHOL
Application Number
207987
Product Number
1
Dosage Form
-
Strength
99% (1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2018-06-21
Regulatory Status
Discontinued
Drug Name
ABLYSINOL
Product Number
2
Dosage Form
-
Strength
99% (5ML)
Approval Date
2018-06-21
Active Ingredient
DEHYDRATED ALCOHOL
Application Number
207987
Product Number
2
Dosage Form
-
Strength
99% (5ML)
Approval Date
2018-06-21
Regulatory Status
RX
Drug Name
EPINEPHRINE
Product Number
1
Dosage Form
-
Strength
1MG/ML (1MG/ML)
Approval Date
2014-07-29
Active Ingredient
EPINEPHRINE
Application Number
205029
Product Number
1
Dosage Form
-
Strength
1MG/ML (1MG/ML)
Approval Date
2014-07-29
Regulatory Status
RX
Drug Name
EPINEPHRINE
Product Number
2
Dosage Form
-
Strength
10MG/10ML (1MG/ML)
Approval Date
2022-02-04
Active Ingredient
EPINEPHRINE
Application Number
205029
Product Number
2
Dosage Form
-
Strength
10MG/10ML (1MG/ML)
Approval Date
2022-02-04
Regulatory Status
RX
Drug Name
EPINEPHRINE
Product Number
3
Dosage Form
-
Strength
1MG/ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2023-05-12
Active Ingredient
EPINEPHRINE
Application Number
205029
Product Number
3
Dosage Form
-
Strength
1MG/ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2023-05-12
Regulatory Status
Discontinued
Drug Name
EPINEPHRINE
Product Number
4
Dosage Form
-
Strength
30MG/30ML (1MG/ML)
Approval Date
2024-02-14
Active Ingredient
EPINEPHRINE
Application Number
205029
Product Number
4
Dosage Form
-
Strength
30MG/30ML (1MG/ML)
Approval Date
2024-02-14
Regulatory Status
RX
Drug Name
EPINEPHRINE
Product Number
5
Dosage Form
-
Strength
1MG/ML (1MG/ML)
Approval Date
2024-03-04
Active Ingredient
EPINEPHRINE
Application Number
205029
Product Number
5
Dosage Form
-
Strength
1MG/ML (1MG/ML)
Approval Date
2024-03-04
Regulatory Status
RX
Drug Name
FLUORESCEIN SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/5ML (EQ 100MG BASE/ML)
Approval Date
2026-04-30
Active Ingredient
FLUORESCEIN SODIUM
Application Number
220046
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/5ML (EQ 100MG BASE/ML)
Approval Date
2026-04-30
Regulatory Status
RX
Drug Name
MELPHALAN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE/VIAL
Approval Date
2020-05-08
Active Ingredient
MELPHALAN HYDROCHLORIDE
Application Number
209197
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE/VIAL
Approval Date
2020-05-08
Regulatory Status
RX
Drug Name
MYCOPHENOLATE MOFETIL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
500MG/VIAL
Approval Date
2023-06-01
Active Ingredient
MYCOPHENOLATE MOFETIL HYDROCHLORIDE
Application Number
214283
Product Number
1
Dosage Form
-
Strength
500MG/VIAL
Approval Date
2023-06-01
Regulatory Status
RX
Drug Name
NALOXONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2023-10-06
Active Ingredient
NALOXONE HYDROCHLORIDE
Application Number
216977
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2023-10-06
Regulatory Status
RX
Drug Name
PENTOBARBITAL SODIUM
Product Number
1
Dosage Form
-
Strength
50MG/ML
Approval Date
2017-11-27
Active Ingredient
PENTOBARBITAL SODIUM
Application Number
206677
Product Number
1
Dosage Form
-
Strength
50MG/ML
Approval Date
2017-11-27
Regulatory Status
RX
Drug Name
TRIMETHOBENZAMIDE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
2025-10-16
Active Ingredient
TRIMETHOBENZAMIDE HYDROCHLORIDE
Application Number
219606
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
2025-10-16
Regulatory Status
RX
Drug Name
ZOLEDRONIC ACID
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE/5ML
Approval Date
2017-12-29
Active Ingredient
ZOLEDRONIC ACID
Application Number
207341
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE/5ML
Approval Date
2017-12-29
Regulatory Status
RX
Drug Status Breakdown
14 total- Discontinued
- RX
Official Source
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Drug Name
ABLYSINOL
Application Number
207987
Product Number
1
Active Ingredient
DEHYDRATED ALCOHOL
Dosage Form
-
Strength
99% (1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
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