Details for New Drug Application (NDA): 206183
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NDA 206183 describes PRALATREXATE, which is a drug marketed by Dr Reddys and is included in one NDA. It is available from one supplier. Additional details are available on the PRALATREXATE profile page.
The generic ingredient in PRALATREXATE is pralatrexate. There are two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the pralatrexate profile page.
The generic ingredient in PRALATREXATE is pralatrexate. There are two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the pralatrexate profile page.
Summary for 206183
| Tradename: | PRALATREXATE |
| Applicant: | Dr Reddys |
| Ingredient: | pralatrexate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 206183
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PRALATREXATE | pralatrexate | SOLUTION;INTRAVENOUS | 206183 | ANDA | Dr.Reddy's Laboratories Inc., | 43598-342 | 43598-342-11 | 1 VIAL, SINGLE-DOSE in 1 CARTON (43598-342-11) / 1 mL in 1 VIAL, SINGLE-DOSE |
| PRALATREXATE | pralatrexate | SOLUTION;INTRAVENOUS | 206183 | ANDA | Dr.Reddy's Laboratories Inc., | 43598-343 | 43598-343-23 | 1 VIAL, SINGLE-DOSE in 1 CARTON (43598-343-23) / 2 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 20MG/ML (20MG/ML) | ||||
| Approval Date: | Mar 10, 2025 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 40MG/2ML (20MG/ML) | ||||
| Approval Date: | Mar 10, 2025 | TE: | AP | RLD: | No | ||||
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