Details for New Drug Application (NDA): 206107
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The generic ingredient in ASENAPINE MALEATE is asenapine maleate. There are twelve drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the asenapine maleate profile page.
Summary for 206107
Tradename: | ASENAPINE MALEATE |
Applicant: | Sigmapharm Labs Llc |
Ingredient: | asenapine maleate |
Patents: | 0 |
Suppliers and Packaging for NDA: 206107
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ASENAPINE MALEATE | asenapine maleate | TABLET;SUBLINGUAL | 206107 | ANDA | Sigmapharm Laboratories, LLC | 42794-016 | 42794-016-08 | 30 TABLET in 1 BOTTLE, PLASTIC (42794-016-08) |
ASENAPINE MALEATE | asenapine maleate | TABLET;SUBLINGUAL | 206107 | ANDA | Sigmapharm Laboratories, LLC | 42794-016 | 42794-016-10 | 60 TABLET in 1 BOTTLE, PLASTIC (42794-016-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;SUBLINGUAL | Strength | EQ 5MG BASE | ||||
Approval Date: | Dec 10, 2020 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;SUBLINGUAL | Strength | EQ 10MG BASE | ||||
Approval Date: | Dec 10, 2020 | TE: | AB | RLD: | No |
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