Details for New Drug Application (NDA): 208313
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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 |
Formulation / Manufacturing: | see details |
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? |
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