Otsuka America Pharmaceutical, Inc.
FDA Approved Drugs

Otsuka America Pharmaceutical, Inc.

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.

Discontinued RX
  • Total Records 3
  • Latest Approval Date Oct 29, 2010
  • Data Source FDA
  • First Approval Date Sep 17, 1996
All
3
View
Discontinued
2
View
RX
1
View
Company Overview

Company

Otsuka America Pharmaceutical, Inc.

Country

U.S.A

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Company Snapshot

Otsuka America Pharmaceutical, Inc.

2440 Research Blvd, Rockville, MD 20850

U.S.A

www.otsuka-us.com/ Kimberly.Whitefield@otsuka-us.com View on Map
FDA Approved Drug Records ( 3 records )
2001
10 May
Discontinued Application: 20586

Drug Name

BREATHTEK UBT FOR H-PYLORI

Product Number

2

Dosage Form

-

Strength

EQ 75MG/POUCH

Approval Date

2001-05-10

20586 / 2

Active Ingredient

UREA C-13

Application Number

20586

Product Number

2

Dosage Form

-

Strength

EQ 75MG/POUCH

Approval Date

2001-05-10

Regulatory Status

Discontinued

1996
17 Sep
Discontinued Application: 20586

Drug Name

MERETEK UBT KIT (W/ PRANACTIN)

Product Number

1

Dosage Form

-

Strength

125MG/VIAL

Approval Date

1996-09-17

20586 / 1

Active Ingredient

UREA C-13

Application Number

20586

Product Number

1

Dosage Form

-

Strength

125MG/VIAL

Approval Date

1996-09-17

Regulatory Status

Discontinued

2010
29 Oct
RX Application: 21879

Drug Name

NUEDEXTA

Product Number

1

Dosage Form

-

Strength

20MG;10MG

Approval Date

2010-10-29

21879 / 1

Active Ingredient

DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE

Application Number

21879

Product Number

1

Dosage Form

-

Strength

20MG;10MG

Approval Date

2010-10-29

Regulatory Status

RX

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Drug Status Breakdown
3 total
  • Discontinued
  • RX
Official Source

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

Visit FDA Orange Book
FDA Approved Drug Record Details Preview

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

Drug Name

BREATHTEK UBT FOR H-PYLORI

Application Number

20586

Product Number

2

Active Ingredient

UREA C-13

Dosage Form

-

Strength

EQ 75MG/POUCH

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