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Details for New Drug Application (NDA): 040070

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NDA 040070 describes PREDNISOLONE SODIUM PHOSPHATE, which is a drug marketed by Vintage, Pharm Assoc, Vintage Pharms, Watson Labs, Alcon Pharms Ltd, Amneal Pharms, Medicis Pharms, Akorn, Edenbridge Pharms, Bausch And Lomb, Sola Barnes Hind, Mylan Pharms Inc, We Pharms, Nesher Pharms, Hi Tech Pharma, Paddock Llc, Wockhardt, and Mission Pharma, and is included in twenty-eight NDAs. It is available from twenty-one suppliers. Additional details are available on the PREDNISOLONE SODIUM PHOSPHATE profile page.

The generic ingredient in PREDNISOLONE SODIUM PHOSPHATE is prednisolone sodium phosphate. There are eighty-five drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the prednisolone sodium phosphate profile page.

Summary for NDA: 040070

Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Inflammatory Bowel Disease Agents
Ophthalmic Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 040070

Suppliers and Packaging for NDA: 040070

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
prednisolone sodium phosphate
SOLUTION/DROPS;OPHTHALMIC 040070 ANDA Butler Animal Health Supply 11695-1431 11695-1431-5 1 BOTTLE, DROPPER in 1 CARTON (11695-1431-5) > 5 mL in 1 BOTTLE, DROPPER
prednisolone sodium phosphate
SOLUTION/DROPS;OPHTHALMIC 040070 ANDA MWI/VetOne 13985-025 13985-025-02 1 BOTTLE, DROPPER in 1 CARTON (13985-025-02) > 5 mL in 1 BOTTLE, DROPPER

Summary for product number 001

Approval Date:Jul 29, 1994TE:RLD:No

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