Details for New Drug Application (NDA): 204406
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The generic ingredient in TOPOTECAN HYDROCHLORIDE is topotecan hydrochloride. There are ten drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the topotecan hydrochloride profile page.
Summary for 204406
Tradename: | TOPOTECAN HYDROCHLORIDE |
Applicant: | Accord Hlthcare |
Ingredient: | topotecan hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 204406
Mechanism of Action | Topoisomerase Inhibitors |
Medical Subject Heading (MeSH) Categories for 204406
Suppliers and Packaging for NDA: 204406
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TOPOTECAN HYDROCHLORIDE | topotecan hydrochloride | SOLUTION;INTRAVENOUS | 204406 | ANDA | Accord Healthcare Inc. | 16729-243 | 16729-243-31 | 1 VIAL, MULTI-DOSE in 1 CARTON (16729-243-31) / 4 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | ||||
Approval Date: | Jul 6, 2017 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) | ||||
Approval Date: | Jul 6, 2017 | TE: | AP | RLD: | No |
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