HQ SPCLT PHARMA RX
FDA Approved Drugs
HQ SPCLT PHARMA 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.
- Total Records 33
- Latest Approval Date Nov 18, 2025
- Data Source FDA
- First Approval Date Jan 01, 1982
Company Snapshot
FDA Approved Drug Records ( 33 records )
Drug Name
CALCIUM GLUCONATE
Product Number
4
Dosage Form
-
Strength
10GM/100ML (100MG/ML)
Approval Date
2025-11-18
Active Ingredient
CALCIUM GLUCONATE
Application Number
210906
Product Number
4
Dosage Form
-
Strength
10GM/100ML (100MG/ML)
Approval Date
2025-11-18
Regulatory Status
RX
Drug Name
CALCIUM GLUCONATE IN SODIUM CHLORIDE
Product Number
1
Dosage Form
-
Strength
1GM/50ML (20MG/ML)
Approval Date
2018-10-29
Active Ingredient
CALCIUM GLUCONATE
Application Number
210906
Product Number
1
Dosage Form
-
Strength
1GM/50ML (20MG/ML)
Approval Date
2018-10-29
Regulatory Status
RX
Drug Name
CALCIUM GLUCONATE IN SODIUM CHLORIDE
Product Number
2
Dosage Form
-
Strength
2GM/100ML (20MG/ML)
Approval Date
2018-10-29
Active Ingredient
CALCIUM GLUCONATE
Application Number
210906
Product Number
2
Dosage Form
-
Strength
2GM/100ML (20MG/ML)
Approval Date
2018-10-29
Regulatory Status
RX
Drug Name
CALCIUM GLUCONATE IN SODIUM CHLORIDE
Product Number
3
Dosage Form
-
Strength
1GM/100ML (10MG/ML)
Approval Date
2021-06-04
Active Ingredient
CALCIUM GLUCONATE
Application Number
210906
Product Number
3
Dosage Form
-
Strength
1GM/100ML (10MG/ML)
Approval Date
2021-06-04
Regulatory Status
RX
Drug Name
CEFAZOLIN SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 2GM BASE/VIAL
Approval Date
2023-05-08
Active Ingredient
CEFAZOLIN SODIUM
Application Number
211413
Product Number
1
Dosage Form
-
Strength
EQ 2GM BASE/VIAL
Approval Date
2023-05-08
Regulatory Status
RX
Drug Name
CEFAZOLIN SODIUM
Product Number
2
Dosage Form
-
Strength
EQ 3GM BASE/VIAL
Approval Date
2024-03-08
Active Ingredient
CEFAZOLIN SODIUM
Application Number
211413
Product Number
2
Dosage Form
-
Strength
EQ 3GM BASE/VIAL
Approval Date
2024-03-08
Regulatory Status
RX
Drug Name
CISPLATIN
Product Number
2
Dosage Form
-
Strength
50MG/VIAL
Approval Date
1982-01-01
Active Ingredient
CISPLATIN
Application Number
18057
Product Number
2
Dosage Form
-
Strength
50MG/VIAL
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
CISPLATIN
Product Number
4
Dosage Form
-
Strength
1MG/ML
Approval Date
1988-11-08
Active Ingredient
CISPLATIN
Application Number
18057
Product Number
4
Dosage Form
-
Strength
1MG/ML
Approval Date
1988-11-08
Regulatory Status
RX
Drug Name
DEXMEDETOMIDINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)
Approval Date
2015-10-21
Active Ingredient
DEXMEDETOMIDINE HYDROCHLORIDE
Application Number
206628
Product Number
1
Dosage Form
-
Strength
EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)
Approval Date
2015-10-21
Regulatory Status
RX
Drug Name
DEXMEDETOMIDINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)
Approval Date
2015-10-21
Active Ingredient
DEXMEDETOMIDINE HYDROCHLORIDE
Application Number
206628
Product Number
2
Dosage Form
-
Strength
EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)
Approval Date
2015-10-21
Regulatory Status
RX
Drug Name
DEXMEDETOMIDINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)
Approval Date
2018-06-22
Active Ingredient
DEXMEDETOMIDINE HYDROCHLORIDE
Application Number
206628
Product Number
3
Dosage Form
-
Strength
EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)
Approval Date
2018-06-22
Regulatory Status
RX
Drug Name
DEXMEDETOMIDINE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)
Approval Date
2018-06-22
Active Ingredient
DEXMEDETOMIDINE HYDROCHLORIDE
Application Number
206628
Product Number
4
Dosage Form
-
Strength
EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)
Approval Date
2018-06-22
Regulatory Status
RX
Drug Name
DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE
Product Number
1
Dosage Form
-
Strength
100MG/100ML (1MG/ML)
Approval Date
2025-02-21
Active Ingredient
DILTIAZEM HYDROCHLORIDE
Application Number
218038
Product Number
1
Dosage Form
-
Strength
100MG/100ML (1MG/ML)
Approval Date
2025-02-21
Regulatory Status
RX
Drug Name
DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE
Product Number
2
Dosage Form
-
Strength
250MG/250ML (1MG/ML)
Approval Date
2025-02-21
Active Ingredient
DILTIAZEM HYDROCHLORIDE
Application Number
218038
Product Number
2
Dosage Form
-
Strength
250MG/250ML (1MG/ML)
Approval Date
2025-02-21
Regulatory Status
RX
Drug Name
ESMOLOL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
1GM/100ML
Approval Date
2022-12-02
Active Ingredient
ESMOLOL HYDROCHLORIDE
Application Number
214172
Product Number
1
Dosage Form
-
Strength
1GM/100ML
Approval Date
2022-12-02
Regulatory Status
RX
Drug Name
ESMOLOL HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
2GM/100ML
Approval Date
2022-12-02
Active Ingredient
ESMOLOL HYDROCHLORIDE
Application Number
214172
Product Number
2
Dosage Form
-
Strength
2GM/100ML
Approval Date
2022-12-02
Regulatory Status
RX
Drug Name
ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER
Product Number
2
Dosage Form
-
Strength
2GM/100ML (20MG/ML)
Approval Date
2016-04-07
Active Ingredient
ESMOLOL HYDROCHLORIDE
Application Number
205703
Product Number
2
Dosage Form
-
Strength
2GM/100ML (20MG/ML)
Approval Date
2016-04-07
Regulatory Status
RX
Drug Name
ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER
Product Number
1
Dosage Form
-
Strength
2.5GM/250ML (10MG/ML)
Approval Date
2016-04-07
Active Ingredient
ESMOLOL HYDROCHLORIDE
Application Number
205703
Product Number
1
Dosage Form
-
Strength
2.5GM/250ML (10MG/ML)
Approval Date
2016-04-07
Regulatory Status
RX
Drug Name
IMIPENEM AND CILASTATIN
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL;500MG/VIAL
Approval Date
2019-12-12
Active Ingredient
CILASTATIN SODIUM; IMIPENEM
Application Number
207594
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL;500MG/VIAL
Approval Date
2019-12-12
Regulatory Status
RX
Drug Name
LEVETIRACETAM IN SODIUM CHLORIDE
Product Number
1
Dosage Form
-
Strength
500MG/100ML (5MG/ML)
Approval Date
2011-11-09
Active Ingredient
LEVETIRACETAM
Application Number
202543
Product Number
1
Dosage Form
-
Strength
500MG/100ML (5MG/ML)
Approval Date
2011-11-09
Regulatory Status
RX
Drug Name
LEVETIRACETAM IN SODIUM CHLORIDE
Product Number
2
Dosage Form
-
Strength
1GM/100ML (10MG/ML)
Approval Date
2011-11-09
Active Ingredient
LEVETIRACETAM
Application Number
202543
Product Number
2
Dosage Form
-
Strength
1GM/100ML (10MG/ML)
Approval Date
2011-11-09
Regulatory Status
RX
Drug Name
LEVETIRACETAM IN SODIUM CHLORIDE
Product Number
3
Dosage Form
-
Strength
1.5GM/100ML (15MG/ML)
Approval Date
2011-11-09
Active Ingredient
LEVETIRACETAM
Application Number
202543
Product Number
3
Dosage Form
-
Strength
1.5GM/100ML (15MG/ML)
Approval Date
2011-11-09
Regulatory Status
RX
Drug Name
LINEZOLID
Product Number
1
Dosage Form
-
Strength
200MG/100ML (2MG/ML)
Approval Date
2017-07-07
Active Ingredient
LINEZOLID
Application Number
207001
Product Number
1
Dosage Form
-
Strength
200MG/100ML (2MG/ML)
Approval Date
2017-07-07
Regulatory Status
RX
Drug Name
LINEZOLID
Product Number
2
Dosage Form
-
Strength
600MG/300ML (2MG/ML)
Approval Date
2017-07-07
Active Ingredient
LINEZOLID
Application Number
207001
Product Number
2
Dosage Form
-
Strength
600MG/300ML (2MG/ML)
Approval Date
2017-07-07
Regulatory Status
RX
Drug Name
MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER
Product Number
1
Dosage Form
-
Strength
1GM/100ML
Approval Date
2016-03-02
Active Ingredient
MAGNESIUM SULFATE
Application Number
207349
Product Number
1
Dosage Form
-
Strength
1GM/100ML
Approval Date
2016-03-02
Regulatory Status
RX
Drug Name
MAGNESIUM SULFATE IN PLASTIC CONTAINER
Product Number
1
Dosage Form
-
Strength
2GM/50ML (40MG/ML)
Approval Date
2017-12-06
Active Ingredient
MAGNESIUM SULFATE
Application Number
207350
Product Number
1
Dosage Form
-
Strength
2GM/50ML (40MG/ML)
Approval Date
2017-12-06
Regulatory Status
RX
Drug Name
MAGNESIUM SULFATE IN PLASTIC CONTAINER
Product Number
2
Dosage Form
-
Strength
4GM/100ML (40MG/ML)
Approval Date
2017-12-06
Active Ingredient
MAGNESIUM SULFATE
Application Number
207350
Product Number
2
Dosage Form
-
Strength
4GM/100ML (40MG/ML)
Approval Date
2017-12-06
Regulatory Status
RX
Drug Name
MAGNESIUM SULFATE IN PLASTIC CONTAINER
Product Number
3
Dosage Form
-
Strength
4GM/50ML (80MG/ML)
Approval Date
2017-12-06
Active Ingredient
MAGNESIUM SULFATE
Application Number
207350
Product Number
3
Dosage Form
-
Strength
4GM/50ML (80MG/ML)
Approval Date
2017-12-06
Regulatory Status
RX
Drug Name
MAGNESIUM SULFATE IN PLASTIC CONTAINER
Product Number
4
Dosage Form
-
Strength
20GM/500ML (40MG/ML)
Approval Date
2017-12-06
Active Ingredient
MAGNESIUM SULFATE
Application Number
207350
Product Number
4
Dosage Form
-
Strength
20GM/500ML (40MG/ML)
Approval Date
2017-12-06
Regulatory Status
RX
Drug Name
MAGNESIUM SULFATE IN PLASTIC CONTAINER
Product Number
5
Dosage Form
-
Strength
40GM/1000ML (40MG/ML)
Approval Date
2017-12-06
Active Ingredient
MAGNESIUM SULFATE
Application Number
207350
Product Number
5
Dosage Form
-
Strength
40GM/1000ML (40MG/ML)
Approval Date
2017-12-06
Regulatory Status
RX
Drug Name
MEROPENEM
Product Number
1
Dosage Form
-
Strength
500MG/VIAL
Approval Date
2019-08-16
Active Ingredient
MEROPENEM
Application Number
210773
Product Number
1
Dosage Form
-
Strength
500MG/VIAL
Approval Date
2019-08-16
Regulatory Status
RX
Drug Name
MEROPENEM
Product Number
2
Dosage Form
-
Strength
1GM/VIAL
Approval Date
2019-08-16
Active Ingredient
MEROPENEM
Application Number
210773
Product Number
2
Dosage Form
-
Strength
1GM/VIAL
Approval Date
2019-08-16
Regulatory Status
RX
Drug Name
MEROPENEM
Product Number
1
Dosage Form
-
Strength
2GM/VIAL
Approval Date
2023-07-26
Active Ingredient
MEROPENEM
Application Number
215212
Product Number
1
Dosage Form
-
Strength
2GM/VIAL
Approval Date
2023-07-26
Regulatory Status
RX
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Drug Status Breakdown
33 total- RX
Official Source
FDA approved drug data is based on publicly available U.S. Food and Drug Administration Orange Book information.
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Drug Name
CALCIUM GLUCONATE
Application Number
210906
Product Number
4
Active Ingredient
CALCIUM GLUCONATE
Dosage Form
-
Strength
10GM/100ML (100MG/ML)
FDA Approved Drug Data
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