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Generated: November 17, 2017

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Details for New Drug Application (NDA): 012813

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NDA 012813 describes BLEPHAMIDE, which is a drug marketed by Allergan and is included in two NDAs. It is available from two suppliers. Additional details are available on the BLEPHAMIDE profile page.

The generic ingredient in BLEPHAMIDE is prednisolone acetate; sulfacetamide sodium. There are eighty-six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the prednisolone acetate; sulfacetamide sodium profile page.

Summary for 012813

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 012813

Suppliers and Packaging for NDA: 012813

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BLEPHAMIDE
prednisolone acetate; sulfacetamide sodium
SUSPENSION;OPHTHALMIC 012813 NDA Allergan, Inc. 11980-022 11980-022-05 1 BOTTLE, DROPPER in 1 CARTON (11980-022-05) > 5 mL in 1 BOTTLE, DROPPER
BLEPHAMIDE
prednisolone acetate; sulfacetamide sodium
SUSPENSION;OPHTHALMIC 012813 NDA Allergan, Inc. 11980-022 11980-022-10 1 BOTTLE, DROPPER in 1 CARTON (11980-022-10) > 10 mL in 1 BOTTLE, DROPPER

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;OPHTHALMICStrength0.2%;10%
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes


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Serving leading biopharmaceutical companies globally:

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Healthtrust
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