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Generated: January 18, 2019

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Details for New Drug Application (NDA): 090509

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NDA 090509 describes TACROLIMUS, which is a drug marketed by Accord Hlthcare, Belcher Pharms Llc, Dr Reddys Labs Ltd, Mylan, Panacea Biotec Ltd, Sandoz, Strides Pharma, Watson Labs, Hospira Inc, Fougera Pharms Inc, and Glenmark Pharms Ltd, and is included in eleven NDAs. It is available from eighteen suppliers. Additional details are available on the TACROLIMUS profile page.

The generic ingredient in TACROLIMUS is tacrolimus. There are twenty drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the tacrolimus profile page.
Summary for 090509
Tradename:TACROLIMUS
Applicant:Dr Reddys Labs Ltd
Ingredient:tacrolimus
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 090509
Mechanism of ActionCalcineurin Inhibitors
Medical Subject Heading (MeSH) Categories for 090509
Suppliers and Packaging for NDA: 090509
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TACROLIMUS tacrolimus CAPSULE;ORAL 090509 ANDA Major Pharmaceuticals 0904-6623 0904-6623-61 100 BLISTER PACK in 1 CARTON (0904-6623-61) > 1 CAPSULE in 1 BLISTER PACK
TACROLIMUS tacrolimus CAPSULE;ORAL 090509 ANDA Major Pharmaceuticals 0904-6624 0904-6624-61 100 BLISTER PACK in 1 CARTON (0904-6624-61) > 1 CAPSULE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 0.5MG BASE
Approval Date:May 12, 2010TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 1MG BASE
Approval Date:May 12, 2010TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 5MG BASE
Approval Date:May 12, 2010TE:ABRLD:No

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