Approved Drug Products containing MolPort-001-520-453 listed in the FDA Orange Book. Original Data : FDA Website

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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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02

ALLERGAN

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Not Confirmed

U.S.A

RLD : No

TE Code :

FLUOROMETHOLONE; SULFACETAMIDE SODIUM

Brand Name : FML-S

Dosage Form : SUSPENSION/DROPS;OPHTHALMIC

Dosage Strength : 0.1%;10%

Approval Date : 1989-09-29

Application Number : 19525

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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03

ALLERGAN

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Not Confirmed

U.S.A

RLD : Yes

TE Code :

Brand Name : BLEPH-10

Dosage Form : SOLUTION/DROPS;OPHTHALMIC

Dosage Strength : 10%

Approval Date : 1982-01-01

Application Number : 80028

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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04

ALLERGAN

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Not Confirmed

U.S.A

RLD : No

TE Code :

Brand Name : BLEPH-30

Dosage Form : SOLUTION/DROPS;OPHTHALMIC

Dosage Strength : 30%

Approval Date : 1982-01-01

Application Number : 80028

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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05

ALLERGAN

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Not Confirmed

U.S.A

RLD : No

TE Code :

Brand Name : BLEPH-10

Dosage Form : OINTMENT;OPHTHALMIC

Dosage Strength : 10%

Approval Date : 1982-01-01

Application Number : 84015

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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06

ALLERGAN

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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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07

TARO

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Not Confirmed

U.S.A

RLD : No

TE Code : AB

Brand Name : SULFACETAMIDE SODIUM

Dosage Form : LOTION;TOPICAL

Dosage Strength : 10%

Approval Date : 2009-05-20

Application Number : 78668

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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