Details for New Drug Application (NDA): 215179
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NDA 215179 describes PEMETREXED, which is a drug marketed by Actavis, Shilpa, Accord Hlthcare, Amneal, Apotex, Baxter Hlthcare Corp, Biocon Pharma, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hospira, Jiangsu Hansoh Pharm, Meitheal, Mylan Labs Ltd, Nang Kuang Pharm Co, Prinston Inc, Qilu Pharm Hainan, Waverley Pharma Inc, Zydus Pharms, and Sandoz, and is included in twenty-five NDAs. It is available from three suppliers. There is one patent protecting this drug. Additional details are available on the PEMETREXED profile page.
The generic ingredient in PEMETREXED is pemetrexed ditromethamine. There are twenty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the pemetrexed ditromethamine profile page.
The generic ingredient in PEMETREXED is pemetrexed ditromethamine. There are twenty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the pemetrexed ditromethamine profile page.
Summary for 215179
| Tradename: | PEMETREXED |
| Applicant: | Shilpa |
| Ingredient: | pemetrexed disodium |
| Patents: | 1 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 215179
| Mechanism of Action | Folic Acid Metabolism Inhibitors |
Medical Subject Heading (MeSH) Categories for 215179
Suppliers and Packaging for NDA: 215179
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PEMETREXED | pemetrexed disodium | SOLUTION;INTRAVENOUS | 215179 | NDA | SHILPA MEDICARE LIMITED | 63759-3048 | 63759-3048-1 | 1 VIAL in 1 CARTON (63759-3048-1) / 10 mL in 1 VIAL |
| PEMETREXED | pemetrexed disodium | SOLUTION;INTRAVENOUS | 215179 | NDA | SHILPA MEDICARE LIMITED | 63759-3049 | 63759-3049-1 | 1 VIAL in 1 CARTON (63759-3049-1) / 50 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 100MG/10ML BASE (10MG/ML) | ||||
| Approval Date: | May 22, 2023 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Mar 26, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 500MG/50ML BASE (10MG/ML) | ||||
| Approval Date: | May 22, 2023 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Mar 26, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 1GM/100ML BASE (10MG/ML) | ||||
| Approval Date: | May 22, 2023 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Mar 26, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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