Details for New Drug Application (NDA): 208313
✉ Email this page to a colleague
NDA 208313 describes INFUGEM, which is a drug marketed by Sun Pharm and is included in one NDA. There is one patent protecting this drug. Additional details are available on the INFUGEM profile page.
The generic ingredient in INFUGEM is gemcitabine hydrochloride. There are thirty drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the gemcitabine hydrochloride profile page.
The generic ingredient in INFUGEM is gemcitabine hydrochloride. There are thirty drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the gemcitabine hydrochloride profile page.
Summary for 208313
| Tradename: | INFUGEM |
| Applicant: | Sun Pharm |
| Ingredient: | gemcitabine hydrochloride |
| Patents: | 1 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 1200MG BASE/120ML (EQ 10MG BASE/ML) | ||||
| Approval Date: | Jul 16, 2018 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jul 1, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 1300MG BASE/130ML (EQ 10MG BASE/ML) | ||||
| Approval Date: | Jul 16, 2018 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jul 1, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 1400MG BASE/140ML (EQ 10MG BASE/ML) | ||||
| Approval Date: | Jul 16, 2018 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jul 1, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Complete Access Available with Subscription
