Details for New Drug Application (NDA): 210393
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NDA 210393 describes TACROLIMUS, which is a drug marketed by Chengdu, Accord Hlthcare, Ajenat Pharms, Alkem Labs Ltd, Biocon Pharma, Concord Biotech Ltd, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Hangzhou Zhongmei, Heritage Pharma Avet, Mylan, Panacea, Sandoz, Strides Pharma, Hospira, Nexus, Encube, and Fougera Pharms Inc, and is included in twenty NDAs. It is available from thirty-two 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 210393
| Tradename: | TACROLIMUS |
| Applicant: | Glenmark Pharms Ltd |
| Ingredient: | tacrolimus |
| Patents: | 0 |
Pharmacology for NDA: 210393
| Mechanism of Action | Calcineurin Inhibitors |
Medical Subject Heading (MeSH) Categories for 210393
Suppliers and Packaging for NDA: 210393
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TACROLIMUS | tacrolimus | OINTMENT;TOPICAL | 210393 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-534 | 68462-534-35 | 1 TUBE in 1 CARTON (68462-534-35) / 30 g in 1 TUBE |
| TACROLIMUS | tacrolimus | OINTMENT;TOPICAL | 210393 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-534 | 68462-534-65 | 1 TUBE in 1 CARTON (68462-534-65) / 60 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | OINTMENT;TOPICAL | Strength | 0.1% | ||||
| Approval Date: | Apr 16, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | OINTMENT;TOPICAL | Strength | 0.03% | ||||
| Approval Date: | Aug 16, 2023 | TE: | AB | RLD: | No | ||||
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