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Details for New Drug Application (NDA): 203814

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NDA 203814 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-five 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-four 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: 203814

Macleods Pharms Ltd
sildenafil citrate
Therapeutic Class:Respiratory Tract Agents

Pharmacology for NDA: 203814

Suppliers and Packaging for NDA: 203814

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
sildenafil citrate
TABLET;ORAL 203814 ANDA Macleods Pharmaceuticals Limited 33342-121 33342-121-10 90 TABLET, FILM COATED in 1 BOTTLE (33342-121-10)
sildenafil citrate
TABLET;ORAL 203814 ANDA Macleods Pharmaceuticals Limited 33342-121 33342-121-12 10 TABLET, FILM COATED in 1 BLISTER PACK (33342-121-12)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Dec 17, 2013TE:ABRLD:No

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