Details for New Drug Application (NDA): 203807
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The generic ingredient in CLOZAPINE is clozapine. There are thirteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the clozapine profile page.
Summary for 203807
Tradename: | CLOZAPINE |
Applicant: | Dr Reddys Labs Sa |
Ingredient: | clozapine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 203807
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CLOZAPINE | clozapine | TABLET;ORAL | 203807 | ANDA | Golden State Medical Supply, Inc. | 51407-086 | 51407-086-01 | 100 TABLET in 1 BOTTLE (51407-086-01) |
CLOZAPINE | clozapine | TABLET;ORAL | 203807 | ANDA | Golden State Medical Supply, Inc. | 51407-086 | 51407-086-05 | 500 TABLET in 1 BOTTLE (51407-086-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Sep 17, 2015 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | Sep 17, 2015 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Aug 22, 2017 | TE: | RLD: | No |
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