Pliva Hrvatska RX
FDA Approved Drugs

Pliva Hrvatska RX

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
  • Total Records 30
  • Latest Approval Date Jul 05, 2006
  • Data Source FDA
  • First Approval Date May 01, 1984
All
125
View
Unclassified
3
View
Discontinued
92
View
RX
30
View
Company Overview

Company

Pliva Hrvatska RX

Country

Croatia

Website

Visit Website

Email

tamara.susanj-sulentic@pliva.hr

Social Profiles

Company Snapshot

Pliva Hrvatska RX

PLIVA HRVATSKA d.o.o.Prilaz baruna Filipovića 2510000 Zagreb, Croatia

Croatia

www.pliva.com/ tamara.susanj-sulentic@pliva.hr View on Map
FDA Approved Drug Records ( 30 records )
2005
14 Nov
RX Application: 65218

Drug Name

AZITHROMYCIN

Product Number

1

Dosage Form

-

Strength

EQ 600MG BASE

Approval Date

2005-11-14

65218 / 1

Active Ingredient

AZITHROMYCIN

Application Number

65218

Product Number

1

Dosage Form

-

Strength

EQ 600MG BASE

Approval Date

2005-11-14

Regulatory Status

RX

2005
14 Nov
RX Application: 65223

Drug Name

AZITHROMYCIN

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2005-11-14

65223 / 1

Active Ingredient

AZITHROMYCIN

Application Number

65223

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2005-11-14

Regulatory Status

RX

2005
14 Nov
RX Application: 65225

Drug Name

AZITHROMYCIN

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2005-11-14

65225 / 1

Active Ingredient

AZITHROMYCIN

Application Number

65225

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2005-11-14

Regulatory Status

RX

2006
05 Jul
RX Application: 65246

Drug Name

AZITHROMYCIN

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE/5ML

Approval Date

2006-07-05

65246 / 1

Active Ingredient

AZITHROMYCIN

Application Number

65246

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE/5ML

Approval Date

2006-07-05

Regulatory Status

RX

2006
05 Jul
RX Application: 65246

Drug Name

AZITHROMYCIN

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE/5ML

Approval Date

2006-07-05

65246 / 2

Active Ingredient

AZITHROMYCIN

Application Number

65246

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE/5ML

Approval Date

2006-07-05

Regulatory Status

RX

1988
10 Aug
RX Application: 89058

Drug Name

BENZTROPINE MESYLATE

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

1988-08-10

89058 / 1

Active Ingredient

BENZTROPINE MESYLATE

Application Number

89058

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

1988-08-10

Regulatory Status

RX

1988
10 Aug
RX Application: 89059

Drug Name

BENZTROPINE MESYLATE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

1988-08-10

89059 / 1

Active Ingredient

BENZTROPINE MESYLATE

Application Number

89059

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

1988-08-10

Regulatory Status

RX

1988
10 Aug
RX Application: 89060

Drug Name

BENZTROPINE MESYLATE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1988-08-10

89060 / 1

Active Ingredient

BENZTROPINE MESYLATE

Application Number

89060

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1988-08-10

Regulatory Status

RX

1984
01 May
RX Application: 88467

Drug Name

HYDRALAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1984-05-01

88467 / 1

Active Ingredient

HYDRALAZINE HYDROCHLORIDE

Application Number

88467

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1984-05-01

Regulatory Status

RX

1984
01 May
RX Application: 88468

Drug Name

HYDRALAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1984-05-01

88468 / 1

Active Ingredient

HYDRALAZINE HYDROCHLORIDE

Application Number

88468

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1984-05-01

Regulatory Status

RX

1985
18 Dec
RX Application: 89097

Drug Name

HYDRALAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1985-12-18

89097 / 1

Active Ingredient

HYDRALAZINE HYDROCHLORIDE

Application Number

89097

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1985-12-18

Regulatory Status

RX

1985
18 Dec
RX Application: 89098

Drug Name

HYDRALAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1985-12-18

89098 / 1

Active Ingredient

HYDRALAZINE HYDROCHLORIDE

Application Number

89098

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1985-12-18

Regulatory Status

RX

1986
10 Jan
RX Application: 88617

Drug Name

HYDROXYZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1986-01-10

88617 / 1

Active Ingredient

HYDROXYZINE HYDROCHLORIDE

Application Number

88617

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1986-01-10

Regulatory Status

RX

1986
10 Jan
RX Application: 88618

Drug Name

HYDROXYZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1986-01-10

88618 / 1

Active Ingredient

HYDROXYZINE HYDROCHLORIDE

Application Number

88618

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1986-01-10

Regulatory Status

RX

1986
10 Jan
RX Application: 88619

Drug Name

HYDROXYZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1986-01-10

88619 / 1

Active Ingredient

HYDROXYZINE HYDROCHLORIDE

Application Number

88619

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1986-01-10

Regulatory Status

RX

1984
06 Dec
RX Application: 70033

Drug Name

METRONIDAZOLE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1984-12-06

70033 / 1

Active Ingredient

METRONIDAZOLE

Application Number

70033

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1984-12-06

Regulatory Status

RX

2003
30 May
RX Application: 76346

Drug Name

TORSEMIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2003-05-30

76346 / 1

Active Ingredient

TORSEMIDE

Application Number

76346

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2003-05-30

Regulatory Status

RX

2003
30 May
RX Application: 76346

Drug Name

TORSEMIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2003-05-30

76346 / 2

Active Ingredient

TORSEMIDE

Application Number

76346

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2003-05-30

Regulatory Status

RX

2003
30 May
RX Application: 76346

Drug Name

TORSEMIDE

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2003-05-30

76346 / 3

Active Ingredient

TORSEMIDE

Application Number

76346

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2003-05-30

Regulatory Status

RX

2004
19 Oct
RX Application: 76346

Drug Name

TORSEMIDE

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2004-10-19

76346 / 4

Active Ingredient

TORSEMIDE

Application Number

76346

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2004-10-19

Regulatory Status

RX

1988
09 Mar
RX Application: 71525

Drug Name

TRAZODONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

1988-03-09

71525 / 1

Active Ingredient

TRAZODONE HYDROCHLORIDE

Application Number

71525

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

1988-03-09

Regulatory Status

RX

2006
05 Jul
RX Application: 40616

Drug Name

WARFARIN SODIUM

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2006-07-05

40616 / 1

Active Ingredient

WARFARIN SODIUM

Application Number

40616

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2006-07-05

Regulatory Status

RX

2006
05 Jul
RX Application: 40616

Drug Name

WARFARIN SODIUM

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

2006-07-05

40616 / 2

Active Ingredient

WARFARIN SODIUM

Application Number

40616

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

2006-07-05

Regulatory Status

RX

2006
05 Jul
RX Application: 40616

Drug Name

WARFARIN SODIUM

Product Number

3

Dosage Form

-

Strength

3MG

Approval Date

2006-07-05

40616 / 3

Active Ingredient

WARFARIN SODIUM

Application Number

40616

Product Number

3

Dosage Form

-

Strength

3MG

Approval Date

2006-07-05

Regulatory Status

RX

2006
05 Jul
RX Application: 40616

Drug Name

WARFARIN SODIUM

Product Number

4

Dosage Form

-

Strength

4MG

Approval Date

2006-07-05

40616 / 4

Active Ingredient

WARFARIN SODIUM

Application Number

40616

Product Number

4

Dosage Form

-

Strength

4MG

Approval Date

2006-07-05

Regulatory Status

RX

2006
05 Jul
RX Application: 40616

Drug Name

WARFARIN SODIUM

Product Number

5

Dosage Form

-

Strength

5MG

Approval Date

2006-07-05

40616 / 5

Active Ingredient

WARFARIN SODIUM

Application Number

40616

Product Number

5

Dosage Form

-

Strength

5MG

Approval Date

2006-07-05

Regulatory Status

RX

2006
05 Jul
RX Application: 40616

Drug Name

WARFARIN SODIUM

Product Number

6

Dosage Form

-

Strength

6MG

Approval Date

2006-07-05

40616 / 6

Active Ingredient

WARFARIN SODIUM

Application Number

40616

Product Number

6

Dosage Form

-

Strength

6MG

Approval Date

2006-07-05

Regulatory Status

RX

2006
05 Jul
RX Application: 40616

Drug Name

WARFARIN SODIUM

Product Number

7

Dosage Form

-

Strength

7.5MG

Approval Date

2006-07-05

40616 / 7

Active Ingredient

WARFARIN SODIUM

Application Number

40616

Product Number

7

Dosage Form

-

Strength

7.5MG

Approval Date

2006-07-05

Regulatory Status

RX

2006
05 Jul
RX Application: 40616

Drug Name

WARFARIN SODIUM

Product Number

8

Dosage Form

-

Strength

10MG

Approval Date

2006-07-05

40616 / 8

Active Ingredient

WARFARIN SODIUM

Application Number

40616

Product Number

8

Dosage Form

-

Strength

10MG

Approval Date

2006-07-05

Regulatory Status

RX

2006
05 Jul
RX Application: 40616

Drug Name

WARFARIN SODIUM

Product Number

9

Dosage Form

-

Strength

1MG

Approval Date

2006-07-05

40616 / 9

Active Ingredient

WARFARIN SODIUM

Application Number

40616

Product Number

9

Dosage Form

-

Strength

1MG

Approval Date

2006-07-05

Regulatory Status

RX

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Drug Status Breakdown
30 total
  • 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

AZITHROMYCIN

Application Number

65218

Product Number

1

Active Ingredient

AZITHROMYCIN

Dosage Form

-

Strength

EQ 600MG BASE

FDA Approved Drug Data

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