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Details for New Drug Application (NDA): 203988

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NDA 203988 describes SILDENAFIL CITRATE, which is a drug marketed by Watson Labs Inc, Macleods Pharms Ltd, Hetero Labs Ltd V, Amneal Pharms, Teva, Actavis Grp Ptc, Mylan Pharms Inc, Aurobindo Pharma Ltd, Apotex Corp, Torrent Pharms Ltd, Teva Pharms, Rubicon Res Pvt Ltd, and Dr Reddys Labs Ltd, and is included in fourteen NDAs. It is available from twenty-six suppliers. Additional details are available on the SILDENAFIL CITRATE profile page.

The generic ingredient in SILDENAFIL CITRATE is sildenafil citrate. There are twenty drug master file entries for this compound. Thirty-five suppliers are listed for this compound. There are thirty-three tentative approvals for this compound. Additional details are available on the sildenafil citrate profile page.

Summary for NDA: 203988

Tradename:
SILDENAFIL CITRATE
Applicant:
Aurobindo Pharma Ltd
Ingredient:
sildenafil citrate
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 203988

Suppliers and Packaging for NDA: 203988

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SILDENAFIL CITRATE
sildenafil citrate
SOLUTION;INTRAVENOUS 203988 ANDA AuroMedics Pharma LLC 55150-166 55150-166-13 1 VIAL, SINGLE-USE in 1 CARTON (55150-166-13) > 12.5 mL in 1 VIAL, SINGLE-USE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrengthEQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)
Approval Date:Apr 1, 2015TE:APRLD:No


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