Details for New Drug Application (NDA): 091195
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NDA 091195 describes TACROLIMUS, which is a drug marketed by Chengdu, Accord Hlthcare, Alkem Labs Ltd, Belcher, Biocon Pharma, Concord Biotech Ltd, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Hangzhou Zhongmei, Heritage Pharma Avet, Mylan, Panacea, Sandoz, Strides Pharma, Hospira, Encube, and Fougera Pharms Inc, and is included in nineteen NDAs. It is available from thirty-one 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. Thirty-five suppliers are listed for this compound. 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. Thirty-five suppliers are listed for this compound. Additional details are available on the tacrolimus profile page.
Summary for 091195
| Tradename: | TACROLIMUS |
| Applicant: | Accord Hlthcare |
| Ingredient: | tacrolimus |
| Patents: | 0 |
Pharmacology for NDA: 091195
| Mechanism of Action | Calcineurin Inhibitors |
Medical Subject Heading (MeSH) Categories for 091195
Suppliers and Packaging for NDA: 091195
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TACROLIMUS | tacrolimus | CAPSULE;ORAL | 091195 | ANDA | Accord Healthcare Inc. | 16729-041 | 16729-041-01 | 100 CAPSULE in 1 BOTTLE (16729-041-01) |
| TACROLIMUS | tacrolimus | CAPSULE;ORAL | 091195 | ANDA | Accord Healthcare Inc. | 16729-042 | 16729-042-01 | 100 CAPSULE in 1 BOTTLE (16729-042-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 0.5MG BASE | ||||
| Approval Date: | Aug 31, 2011 | TE: | BX | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 1MG BASE | ||||
| Approval Date: | Aug 31, 2011 | TE: | BX | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | Aug 31, 2011 | TE: | BX | RLD: | No | ||||
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