DENTSPLY PHARM
FDA Approved Drugs

DENTSPLY PHARM

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 Discontinued
  • Total Records 9
  • Latest Approval Date Dec 19, 2003
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
9
View
Discontinued
7
View
RX
2
View
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Company

DENTSPLY PHARM

Country

U.S.A

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DENTSPLY PHARM

U.S.A

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FDA Approved Drug Records ( 9 records )
1982
01 Jan
RX Application: 21383

Drug Name

CITANEST FORTE DENTAL

Product Number

1

Dosage Form

-

Strength

0.005MG/ML;4%

Approval Date

1982-01-01

21383 / 1

Active Ingredient

EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE

Application Number

21383

Product Number

1

Dosage Form

-

Strength

0.005MG/ML;4%

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 21382

Drug Name

CITANEST PLAIN DENTAL

Product Number

1

Dosage Form

-

Strength

4%

Approval Date

1982-01-01

21382 / 1

Active Ingredient

PRILOCAINE HYDROCHLORIDE

Application Number

21382

Product Number

1

Dosage Form

-

Strength

4%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 21384

Drug Name

DURANEST

Product Number

1

Dosage Form

-

Strength

0.005MG/ML;1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

21384 / 1

Active Ingredient

EPINEPHRINE BITARTRATE; ETIDOCAINE HYDROCHLORIDE

Application Number

21384

Product Number

1

Dosage Form

-

Strength

0.005MG/ML;1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

2003
19 Dec
RX Application: 21451

Drug Name

ORAQIX

Product Number

1

Dosage Form

-

Strength

2.5%;2.5%

Approval Date

2003-12-19

21451 / 1

Active Ingredient

LIDOCAINE; PRILOCAINE

Application Number

21451

Product Number

1

Dosage Form

-

Strength

2.5%;2.5%

Approval Date

2003-12-19

Regulatory Status

RX

1984
21 Aug
Discontinued Application: 88653

Drug Name

POLOCAINE

Product Number

1

Dosage Form

-

Strength

3%

Approval Date

1984-08-21

88653 / 1

Active Ingredient

MEPIVACAINE HYDROCHLORIDE

Application Number

88653

Product Number

1

Dosage Form

-

Strength

3%

Approval Date

1984-08-21

Regulatory Status

Discontinued

1988
14 Apr
Discontinued Application: 89517

Drug Name

POLOCAINE W/ LEVONORDEFRIN

Product Number

1

Dosage Form

-

Strength

0.05MG/ML;2%

Approval Date

1988-04-14

89517 / 1

Active Ingredient

LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE

Application Number

89517

Product Number

1

Dosage Form

-

Strength

0.05MG/ML;2%

Approval Date

1988-04-14

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 21380

Drug Name

XYLOCAINE DENTAL

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1982-01-01

21380 / 1

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

21380

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 21381

Drug Name

XYLOCAINE DENTAL WITH EPINEPHRINE

Product Number

1

Dosage Form

-

Strength

0.01MG/ML;2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

21381 / 1

Active Ingredient

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

Application Number

21381

Product Number

1

Dosage Form

-

Strength

0.01MG/ML;2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 21381

Drug Name

XYLOCAINE DENTAL WITH EPINEPHRINE

Product Number

2

Dosage Form

-

Strength

0.02MG/ML;2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

21381 / 2

Active Ingredient

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

Application Number

21381

Product Number

2

Dosage Form

-

Strength

0.02MG/ML;2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

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Drug Status Breakdown
9 total
  • RX
  • Discontinued
Official Source

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

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FDA Approved Drug Record Details Preview

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

Drug Name

CITANEST FORTE DENTAL

Application Number

21383

Product Number

1

Active Ingredient

EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE

Dosage Form

-

Strength

0.005MG/ML;4%

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