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01 3ACCORD HLTHCARE

02 3ACTAVIS ELIZABETH

03 1AMNEAL

04 3AMNEAL PHARMS

05 3ANNORA PHARMA

06 2ASCOT

07 3AUROBINDO PHARMA

08 2CHARTWELL RX

09 1CMP DEV LLC

10 3GRAVITI PHARMS

11 1HETERO LABS LTD III

12 2IVAX PHARMS

13 3JUBILANT GENERICS

14 2LEDERLE

15 2MUTUAL PHARM

16 4MYLAN

17 3OXFORD PHARMS

18 1PARKE DAVIS

19 5PFIZER

20 1PHARMOBEDIENT

21 4PUREPAC PHARM

22 4SUN PHARM INDUSTRIES

23 2SUPERPHARM

24 2UPSHER SMITH

25 1USL PHARMA

26 2VANGARD

27 1WARNER CHILCOTT

28 5WATSON LABS

29 3ZYDUS PHARMS

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PharmaCompass

01

Peptide Process CMC
Not Confirmed
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Peptide Process CMC
Not Confirmed

SPIRONOLACTONE

Brand Name : SPIRONOLACTONE

Dosage Form : TABLET;ORAL

Dosage Strength : 50MG

Approval Date : 1999-07-29

Application Number : 40353

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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02

Peptide Process CMC
Not Confirmed
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Peptide Process CMC
Not Confirmed

SPIRONOLACTONE

Brand Name : SPIRONOLACTONE

Dosage Form : TABLET;ORAL

Dosage Strength : 100MG

Approval Date : 1999-07-29

Application Number : 40353

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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03

Peptide Process CMC
Not Confirmed
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Peptide Process CMC
Not Confirmed

SPIRONOLACTONE

Brand Name : SPIRONOLACTONE

Dosage Form : TABLET;ORAL

Dosage Strength : 25MG

Approval Date : 2006-03-15

Application Number : 40353

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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04

Peptide Process CMC
Not Confirmed
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Peptide Process CMC
Not Confirmed

SPIRONOLACTONE

Brand Name : ALDACTONE

Dosage Form : TABLET;ORAL

Dosage Strength : 50MG

Approval Date : 1982-12-30

Application Number : 12151

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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05

Peptide Process CMC
Not Confirmed
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Peptide Process CMC
Not Confirmed

SPIRONOLACTONE

Brand Name : ALDACTONE

Dosage Form : TABLET;ORAL

Dosage Strength : 25MG

Approval Date : 1983-12-30

Application Number : 12151

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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06

Peptide Process CMC
Not Confirmed
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Peptide Process CMC
Not Confirmed

SPIRONOLACTONE

Brand Name : ALDACTONE

Dosage Form : TABLET;ORAL

Dosage Strength : 100MG

Approval Date : 1983-12-30

Application Number : 12151

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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07

Peptide Process CMC
Not Confirmed
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Peptide Process CMC
Not Confirmed

HYDROCHLOROTHIAZIDE; SPIRONOLACTONE

Brand Name : ALDACTAZIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 25MG;25MG

Approval Date : 1982-12-30

Application Number : 12616

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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08

Peptide Process CMC
Not Confirmed
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Peptide Process CMC
Not Confirmed

HYDROCHLOROTHIAZIDE; SPIRONOLACTONE

Brand Name : ALDACTAZIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 50MG;50MG

Approval Date : 1982-12-30

Application Number : 12616

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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09

Peptide Process CMC
Not Confirmed
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Peptide Process CMC
Not Confirmed

SPIRONOLACTONE

Brand Name : SPIRONOLACTONE

Dosage Form : TABLET;ORAL

Dosage Strength : 25MG

Approval Date : 2001-08-20

Application Number : 40424

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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10

Peptide Process CMC
Not Confirmed
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Peptide Process CMC
Not Confirmed

SPIRONOLACTONE

Brand Name : SPIRONOLACTONE

Dosage Form : TABLET;ORAL

Dosage Strength : 50MG

Approval Date : 2001-08-20

Application Number : 40424

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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