Details for New Drug Application (NDA): 210383
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NDA 210383 describes GEMCITABINE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Actavis Inc, Actavis Totowa, Am Regent, Apotex, Dr Reddys Labs Ltd, Emcure Pharms Ltd, Fresenius Kabi Usa, Gland, Hameln Rds Gmbh, Hikma, Hikma Intl Pharms, Hospira, Hospira Inc, Jiangsu Hansoh Pharm, Meitheal, Mylan Labs Ltd, Novast Labs, Pharmobedient, Sagent Pharms, Sagent Pharms Inc, Shilpa, Sun Pharm, Teva Pharms, and Teyro Labs, and is included in thirty NDAs. It is available from fourteen suppliers. Additional details are available on the GEMCITABINE HYDROCHLORIDE profile page.
The generic ingredient in GEMCITABINE HYDROCHLORIDE is gemcitabine hydrochloride. There are thirty drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the gemcitabine hydrochloride profile page.
The generic ingredient in GEMCITABINE HYDROCHLORIDE is gemcitabine hydrochloride. There are thirty drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the gemcitabine hydrochloride profile page.
Summary for 210383
| Tradename: | GEMCITABINE HYDROCHLORIDE |
| Applicant: | Novast Labs |
| Ingredient: | gemcitabine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 210383
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Suppliers and Packaging for NDA: 210383
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GEMCITABINE HYDROCHLORIDE | gemcitabine hydrochloride | INJECTABLE;INJECTION | 210383 | ANDA | Ingenus Pharmaceuticals, LLC | 50742-496 | 50742-496-26 | 1 VIAL, SINGLE-DOSE in 1 CARTON (50742-496-26) / 26.3 mL in 1 VIAL, SINGLE-DOSE |
| GEMCITABINE HYDROCHLORIDE | gemcitabine hydrochloride | INJECTABLE;INJECTION | 210383 | ANDA | Ingenus Pharmaceuticals, LLC | 50742-497 | 50742-497-53 | 1 VIAL, SINGLE-DOSE in 1 CARTON (50742-497-53) / 52.6 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 200MG/5.26ML (38MG/ML) | ||||
| Approval Date: | Feb 14, 2019 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1GM/26.3ML (38MG/ML) | ||||
| Approval Date: | Feb 14, 2019 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2GM/52.6ML (38MG/ML) | ||||
| Approval Date: | Feb 14, 2019 | TE: | AP | RLD: | No | ||||
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