Prednisolone Acetate | All | Licensing, EU CTD Dossiers, Formulation Suppliers

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OPRD USA

Not Confirmed

U.S.A

Regulatory Info : RX

Registration Country : USA

PREDNISOLONE ACETATE

Brand Name : PRED FORTE

Dosage Form : SUSPENSION/DROPS;OPHTHALMIC

Dosage Strength : 1%

Packaging :

Approval Date : 1982-01-01

Application Number : 17011

Regulatory Info : RX

Registration Country : USA

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Product Web Link

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02

Allergan Aesthetics

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OPRD USA

Not Confirmed

U.S.A

Regulatory Info : DISCN

Registration Country : USA

PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM

Brand Name : BLEPHAMIDE

Dosage Form : SUSPENSION;OPHTHALMIC

Dosage Strength : 0.2%;10%

Packaging :

Approval Date : 1982-01-01

Application Number : 12813

Regulatory Info : DISCN

Registration Country : USA

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Product Web Link

Corporate PDF

03

AbbVie Inc

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OPRD USA

Not Confirmed

U.S.A

Regulatory Info : RX

Registration Country : USA

PREDNISOLONE ACETATE

Brand Name : PRED MILD

Dosage Form : SUSPENSION/DROPS;OPHTHALMIC

Dosage Strength : 0.12%

Packaging :

Approval Date : 1982-01-01

Application Number : 17100

Regulatory Info : RX

Registration Country : USA

Portfolio PDF

Product Web Link

Corporate PDF

04

AbbVie Inc

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OPRD USA

Not Confirmed

U.S.A

Regulatory Info :

Registration Country : Switzerland

Prednisone acetates

Brand Name : Pred Forte

Dosage Form : Gtt Opht

Dosage Strength : 1%

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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Product Web Link

Corporate PDF

05

AbbVie Inc

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OPRD USA

Not Confirmed

U.S.A

Regulatory Info :

Registration Country : Canada

PREDNISOLONE ACETATE

Brand Name : PRED FORTE

Dosage Form : SUSPENSION

Dosage Strength : 1%/W/V

Packaging : 1ML/5ML/10ML

Approval Date :

Application Number : 301175

Regulatory Info :

Registration Country : Canada

Portfolio PDF

Product Web Link

Corporate PDF

06

AbbVie Inc

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OPRD USA

Not Confirmed

U.S.A

Regulatory Info : Originator

Registration Country : South Africa

Prednisolone acetate

Brand Name : Pred Forte Sterile Eye Suspension

Dosage Form : OPD

Dosage Strength : 10mg/ml

Packaging : 5X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Corporate PDF

07

AbbVie Inc

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OPRD USA

Not Confirmed

U.S.A

Regulatory Info : Originator

Registration Country : South Africa

Prednisolone acetate

Brand Name : Pred Mild Sterile Eye Suspension

Dosage Form : OPD

Dosage Strength : 5mg/ml

Packaging : 5X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Corporate PDF

08

Allergan Aesthetics

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OPRD USA

Not Confirmed

U.S.A

Regulatory Info : DISCN

Registration Country : USA

NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PREDNISOLONE ACETATE

Brand Name : POLY-PRED

Dosage Form : SUSPENSION/DROPS;OPHTHALMIC

Dosage Strength : EQ 0.35% BASE;10,000 UNITS/ML;0.5%

Packaging :

Approval Date : 1982-01-01

Application Number : 50081

Regulatory Info : DISCN

Registration Country : USA

Portfolio PDF

Product Web Link

Corporate PDF

09

Allergan Aesthetics

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OPRD USA

Not Confirmed

U.S.A

Regulatory Info : DISCN

Registration Country : USA

GENTAMICIN SULFATE; PREDNISOLONE ACETATE

Brand Name : PRED-G

Dosage Form : SUSPENSION/DROPS;OPHTHALMIC

Dosage Strength : EQ 0.3% BASE;1%

Packaging :

Approval Date : 1988-06-10

Application Number : 50586

Regulatory Info : DISCN

Registration Country : USA

Portfolio PDF

Product Web Link

Corporate PDF

10

Allergan Aesthetics

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OPRD USA

Not Confirmed

U.S.A

Regulatory Info : DISCN

Registration Country : USA

GENTAMICIN SULFATE; PREDNISOLONE ACETATE

Brand Name : PRED-G

Dosage Form : OINTMENT;OPHTHALMIC

Dosage Strength : EQ 0.3% BASE;0.6%

Packaging :

Approval Date : 1989-12-01

Application Number : 50612

Regulatory Info : DISCN

Registration Country : USA

Portfolio PDF

Product Web Link

Corporate PDF

11

Allergan Aesthetics

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OPRD USA

Not Confirmed

U.S.A

Regulatory Info : DISCN

Registration Country : USA

PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM

Brand Name : BLEPHAMIDE S.O.P.

Dosage Form : OINTMENT;OPHTHALMIC

Dosage Strength : 0.2%;10%

Packaging :

Approval Date : 1986-12-03

Application Number : 87748

Regulatory Info : DISCN

Registration Country : USA

Portfolio PDF

Product Web Link

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12

Actavis Inc

OPRD USA

Not Confirmed

13

Actavis Inc

OPRD USA

Not Confirmed

14

Actavis Inc

OPRD USA

Not Confirmed

15

Actavis Inc

OPRD USA

Not Confirmed

16

Bayer AG

Germany

OPRD USA

Not Confirmed

17

Bayer AG

Germany

OPRD USA

Not Confirmed

18

Bayer AG

Germany

OPRD USA

Not Confirmed

19

Belmar Pharma Solutions

OPRD USA

Not Confirmed

20

Belmar Pharma Solutions

OPRD USA

Not Confirmed

21

Epic Pharma. LLC.

OPRD USA

Not Confirmed

22

Epic Pharma. LLC.

OPRD USA

Not Confirmed

23

Harrow

OPRD USA

Not Confirmed

24

Pfizer Inc

OPRD USA

Not Confirmed

25

Pfizer Inc

OPRD USA

Not Confirmed

26

Pfizer Inc

OPRD USA

Not Confirmed

27

Pfizer Inc

OPRD USA

Not Confirmed

28

Sandoz B2B

Switzerland

OPRD USA

Not Confirmed

29

Taro Pharmaceutical Industries

OPRD USA

Not Confirmed

30

Taro Pharmaceutical Industries