Prednisolone Acetate | FDA Orange Book | Approved Drug Product List

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Pharmtech & Ingredients

Not Confirmed

U.S.A

RLD : Yes

TE Code : AB

Brand Name : PRED FORTE

Dosage Form : SUSPENSION/DROPS;OPHTHALMIC

Dosage Strength : 1%

Approval Date : 1982-01-01

Application Number : 17011

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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02

ALLERGAN

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Pharmtech & Ingredients

Not Confirmed

U.S.A

RLD : Yes

TE Code :

PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM

Brand Name : BLEPHAMIDE

Dosage Form : SUSPENSION;OPHTHALMIC

Dosage Strength : 0.2%;10%

Approval Date : 1982-01-01

Application Number : 12813

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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03

ABBVIE

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Pharmtech & Ingredients

Not Confirmed

U.S.A

RLD : Yes

TE Code :

Brand Name : PRED MILD

Dosage Form : SUSPENSION/DROPS;OPHTHALMIC

Dosage Strength : 0.12%

Approval Date : 1982-01-01

Application Number : 17100

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Product Web Link

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04

ALLERGAN

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Pharmtech & Ingredients

Not Confirmed

U.S.A

RLD : No

TE Code :

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%

Approval Date : 1982-01-01

Application Number : 50081

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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05

ALLERGAN

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Pharmtech & Ingredients

Not Confirmed

U.S.A

RLD : Yes

TE Code :

GENTAMICIN SULFATE; PREDNISOLONE ACETATE

Brand Name : PRED-G

Dosage Form : SUSPENSION/DROPS;OPHTHALMIC

Dosage Strength : EQ 0.3% BASE;1%

Approval Date : 1988-06-10

Application Number : 50586

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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06

ALLERGAN

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Pharmtech & Ingredients

Not Confirmed

U.S.A

RLD : Yes

TE Code :

GENTAMICIN SULFATE; PREDNISOLONE ACETATE

Brand Name : PRED-G

Dosage Form : OINTMENT;OPHTHALMIC

Dosage Strength : EQ 0.3% BASE;0.6%

Approval Date : 1989-12-01

Application Number : 50612

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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07

ALLERGAN

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Pharmtech & Ingredients

Not Confirmed

U.S.A

RLD : No

TE Code :

PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM

Brand Name : BLEPHAMIDE S.O.P.

Dosage Form : OINTMENT;OPHTHALMIC

Dosage Strength : 0.2%;10%

Approval Date : 1986-12-03

Application Number : 87748

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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08

TARO

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Pharmtech & Ingredients

Not Confirmed

U.S.A

RLD : No

TE Code :

Brand Name : FLO-PRED

Dosage Form : SUSPENSION;ORAL

Dosage Strength : EQ 5MG BASE/5ML

Approval Date : 2008-01-17

Application Number : 22067

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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Product Web Link

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09

TARO

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Pharmtech & Ingredients

Not Confirmed

U.S.A

RLD : No

TE Code :

Brand Name : FLO-PRED

Dosage Form : SUSPENSION;ORAL

Dosage Strength : EQ 15MG BASE/5ML

Approval Date : 2008-01-17

Application Number : 22067

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link