BRAINTREE LABS
FDA Approved Drugs

BRAINTREE 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.

Discontinued Unclassified
  • Total Records 7
  • Latest Approval Date Feb 12, 2020
  • Data Source FDA
  • First Approval Date May 25, 2004
All
7
View
Unclassified
3
View
Discontinued
4
View
Company Overview

Company

BRAINTREE LABS

Country

U.S.A

Website

Visit Website

Email

webmaster@braintreelabs.com

Social Profiles

Company Snapshot

BRAINTREE LABS

Braintree Laboratories Inc. 60 Columbian Street West PO Box 850929 Braintree, MA 02185-0929

U.S.A

www.braintreelabs.com/ webmaster@braintreelabs.com View on Map
FDA Approved Drug Records ( 7 records )
2004
25 May
Discontinued Application: 21494

Drug Name

AXID

Product Number

1

Dosage Form

-

Strength

15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2004-05-25

21494 / 1

Active Ingredient

NIZATIDINE

Application Number

21494

Product Number

1

Dosage Form

-

Strength

15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2004-05-25

Regulatory Status

Discontinued

-
Unclassified Application: 21551

Drug Name

HALFLYTELY

Product Number

2

Dosage Form

-

Strength

5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM

Approval Date

-

21551 / 2

Active Ingredient

BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE

Application Number

21551

Product Number

2

Dosage Form

-

Strength

5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM

Approval Date

-

Regulatory Status

Unclassified

2010
16 Jul
Discontinued Application: 21551

Drug Name

HALFLYTELY

Product Number

3

Dosage Form

-

Strength

5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2010-07-16

21551 / 3

Active Ingredient

BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE

Application Number

21551

Product Number

3

Dosage Form

-

Strength

5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2010-07-16

Regulatory Status

Discontinued

-
Unclassified Application: 20698

Drug Name

MIRALAX

Product Number

1

Dosage Form

-

Strength

17GM/SCOOPFUL

Approval Date

-

20698 / 1

Active Ingredient

POLYETHYLENE GLYCOL 3350

Application Number

20698

Product Number

1

Dosage Form

-

Strength

17GM/SCOOPFUL

Approval Date

-

Regulatory Status

Unclassified

2020
12 Feb
Discontinued Application: 211281

Drug Name

PIZENSY

Product Number

1

Dosage Form

-

Strength

10GM

Approval Date

2020-02-12

211281 / 1

Active Ingredient

LACTITOL

Application Number

211281

Product Number

1

Dosage Form

-

Strength

10GM

Approval Date

2020-02-12

Regulatory Status

Discontinued

-
Unclassified Application: 211281

Drug Name

PIZENSY

Product Number

2

Dosage Form

-

Strength

20G

Approval Date

-

211281 / 2

Active Ingredient

LACTITOL

Application Number

211281

Product Number

2

Dosage Form

-

Strength

20G

Approval Date

-

Regulatory Status

Unclassified

2013
18 Jan
Discontinued Application: 203595

Drug Name

SUCLEAR

Product Number

1

Dosage Form

-

Strength

1.6GM/BOT,3.13GM/BOT,17.5GM/BOT,N/A,N/A,N/A,N/A;N/A,N/A,N/A,210GM,0.74GM,2.86GM,5.6GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2013-01-18

203595 / 1

Active Ingredient

MAGNESIUM SULFATE; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; POTASSIUM SULFATE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE

Application Number

203595

Product Number

1

Dosage Form

-

Strength

1.6GM/BOT,3.13GM/BOT,17.5GM/BOT,N/A,N/A,N/A,N/A;N/A,N/A,N/A,210GM,0.74GM,2.86GM,5.6GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2013-01-18

Regulatory Status

Discontinued

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Drug Status Breakdown
7 total
  • 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 Book
FDA Approved Drug Record Details Preview

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

Drug Name

AXID

Application Number

21494

Product Number

1

Active Ingredient

NIZATIDINE

Dosage Form

-

Strength

15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

FDA Approved Drug Data

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