Details for New Drug Application (NDA): 215179
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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 |
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: | ⤷ Sign Up | 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: | ⤷ Sign Up | 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: | ⤷ Sign Up | Patent Expiration: | Mar 26, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? |
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