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List of Drug Master Files (DMF) of Albuterol Sulfate Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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ALBUTEROL /SALBUTAMOL SULPHATE

ALBUTEROL 8 MG, LOT E-14274

ALBUTEROL BASE

ALBUTEROL SULFATE

ALBUTEROL SULFATE (UNMICRONIZED)

ALBUTEROL SULFATE PRESSURISED INHALATION AEROSOL AND MATCHING PLACEBO

ALBUTEROL SULFATE USP

ALBUTEROL SULPHATE

ALBUTEROL SULPHATE (SALBUTAMOL)

ALBUTEROL USP

BENZYL ALBUTEROL, INTERMEDIATE

SALBUTAMOL SULFATE BULK

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GERMANY

INDIA

ISRAEL

ITALY

UNITED STATES

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Inactive

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DMF Number

31034

Status

Active

Submission Date

2016-12-01

GDUFA DMF Review

Complete

GDUFA Review Date

2017-05-18

GDUFA Payment Date

2016-12-07

Type

II

Supporting Information

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DMF Number

14258

Status

Active

Submission Date

1999-06-25

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

Supporting Information

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DMF Number

6522

Status

Active

Submission Date

1986-08-07

GDUFA DMF Review

Complete

GDUFA Review Date

2015-10-07

GDUFA Payment Date

2015-09-24

Type

II

Supporting Information

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DMF Number

6524

Status

Inactive

Submission Date

1986-08-07

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

Supporting Information

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DMF Number

6885

Status

Active

Submission Date

1987-01-20

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

Supporting Information

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DMF Number

16678

Status

Active

Submission Date

2003-06-30

GDUFA DMF Review

Complete

GDUFA Review Date

2015-11-10

GDUFA Payment Date

2015-09-29

Type

II

Supporting Information

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DMF Number

7809

Status

Active

Submission Date

1988-12-12

GDUFA DMF Review

Complete

GDUFA Review Date

2014-06-05

GDUFA Payment Date

2014-05-28

Type

II

Supporting Information

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DMF Number

28997

Status

Active

Submission Date

2015-03-10

GDUFA DMF Review

Complete

GDUFA Review Date

2015-07-07

GDUFA Payment Date

2015-01-27

Type

II

Supporting Information

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DMF Number

26562

Status

Active

Submission Date

2012-10-24

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

Supporting Information

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DMF Number

10253

Status

Active

Submission Date

1993-05-12

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

Supporting Information

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DMF Number

10254

Status

Inactive

Submission Date

1993-05-12

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

Supporting Information

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DMF Number

16371

Status

Active

Submission Date

2003-01-20

GDUFA DMF Review

Complete

GDUFA Review Date

2013-09-26

GDUFA Payment Date

2013-08-29

Type

II

Supporting Information

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DMF Number

30708

Status

Active

Submission Date

2016-06-27

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

Supporting Information

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DMF Number

6618

Status

Active

Submission Date

1986-10-02

GDUFA DMF Review

Complete

GDUFA Review Date

2012-11-30

GDUFA Payment Date

2012-11-13

Type

II

Supporting Information

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HUHTAMAKI OY LEIRAS PHARMACEUTICALS

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DMF Number

7082

Status

Inactive

Submission Date

1987-06-15

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

Supporting Information

RP SCHERER NORTH AMERICA DIV RP SCHERER CO...

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DMF Number

7360

Status

Inactive

Submission Date

1988-02-25

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

Supporting Information

SOL PHARMACEUTICALS LTD

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DMF Number

7750

Status

Inactive

Submission Date

1988-10-28

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

Supporting Information

SOL PHARMACEUTICALS LTD

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DMF Number

8519

Status

Inactive

Submission Date

1990-04-04

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

Supporting Information

PEARL THERAPEUTICS INC

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DMF Number

31995

Status

Active

Submission Date

2017-10-06

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

Supporting Information

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