Details for New Drug Application (NDA): 090912
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NDA 090912 describes ACARBOSE, which is a drug marketed by Avet Lifesciences, Dash Pharms, Hangzhou Zhongmei, Hikma, Impax Labs, Strides Pharma, Virtus Pharm, 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 090912
| Tradename: | ACARBOSE |
| Applicant: | Strides Pharma |
| Ingredient: | acarbose |
| Patents: | 0 |
Pharmacology for NDA: 090912
| Mechanism of Action | alpha Glucosidase Inhibitors |
Medical Subject Heading (MeSH) Categories for 090912
Suppliers and Packaging for NDA: 090912
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ACARBOSE | acarbose | TABLET;ORAL | 090912 | ANDA | A-S Medication Solutions | 50090-4952 | 50090-4952-1 | 30 TABLET in 1 BOTTLE (50090-4952-1) |
| ACARBOSE | acarbose | TABLET;ORAL | 090912 | ANDA | Bryant Ranch Prepack | 63629-5698 | 63629-5698-1 | 30 TABLET in 1 BOTTLE (63629-5698-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Jul 27, 2011 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Jul 27, 2011 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Jul 27, 2011 | TE: | AB | RLD: | No | ||||
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