Details for New Drug Application (NDA): 091343
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NDA 091343 describes ACARBOSE, which is a drug marketed by Avet Lifesciences, Dash Pharms, Hangzhou Zhongmei, Hikma, Impax Labs, Somerset Theraps Llc, Strides Pharma, and Watson Labs, and is included in eight NDAs. It is available from nine suppliers. Additional details are available on the ACARBOSE profile page.
The generic ingredient in ACARBOSE is acarbose. There are six drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the acarbose profile page.
The generic ingredient in ACARBOSE is acarbose. There are six drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the acarbose profile page.
Summary for 091343
| Tradename: | ACARBOSE |
| Applicant: | Somerset Theraps Llc |
| Ingredient: | acarbose |
| Patents: | 0 |
Pharmacology for NDA: 091343
| Mechanism of Action | alpha Glucosidase Inhibitors |
Medical Subject Heading (MeSH) Categories for 091343
Suppliers and Packaging for NDA: 091343
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ACARBOSE | acarbose | TABLET;ORAL | 091343 | ANDA | Virtus Pharmaceuticals LLC | 69543-120 | 69543-120-10 | 100 TABLET in 1 BOTTLE (69543-120-10) |
| ACARBOSE | acarbose | TABLET;ORAL | 091343 | ANDA | Virtus Pharmaceuticals LLC | 69543-120 | 69543-120-11 | 1000 TABLET in 1 BOTTLE (69543-120-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Oct 17, 2013 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Oct 17, 2013 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Oct 17, 2013 | TE: | AB | RLD: | No | ||||
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