Details for New Drug Application (NDA): 219283
✉ Email this page to a colleague
NDA 219283 describes NINTEDANIB ESYLATE, which is a drug marketed by Apotex, Cipla, Dexcel, Dr Reddys, and Sandoz, and is included in five NDAs. It is available from six suppliers. Additional details are available on the NINTEDANIB ESYLATE profile page.
The generic ingredient in NINTEDANIB ESYLATE is nintedanib esylate. There are nine drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the nintedanib esylate profile page.
The generic ingredient in NINTEDANIB ESYLATE is nintedanib esylate. There are nine drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the nintedanib esylate profile page.
Summary for 219283
| Tradename: | NINTEDANIB ESYLATE |
| Applicant: | Dr Reddys |
| Ingredient: | nintedanib esylate |
| Patents: | 0 |
Pharmacology for NDA: 219283
| Mechanism of Action | Protein Kinase Inhibitors |
Suppliers and Packaging for NDA: 219283
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NINTEDANIB ESYLATE | nintedanib esylate | CAPSULE;ORAL | 219283 | ANDA | Dr. Reddy's Laboratories Inc. | 43598-147 | 43598-147-60 | 60 CAPSULE in 1 BOTTLE (43598-147-60) |
| NINTEDANIB ESYLATE | nintedanib esylate | CAPSULE;ORAL | 219283 | ANDA | Dr. Reddy's Laboratories Inc. | 43598-148 | 43598-148-60 | 60 CAPSULE in 1 BOTTLE (43598-148-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 100MG BASE | ||||
| Approval Date: | Apr 2, 2026 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 150MG BASE | ||||
| Approval Date: | Apr 2, 2026 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
