Details for New Drug Application (NDA): 076130
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NDA 076130 describes VOSPIRE ER, which is a drug marketed by Strides Pharma and is included in one NDA. Additional details are available on the VOSPIRE ER profile page.
The generic ingredient in VOSPIRE ER is albuterol sulfate. There are thirty-eight drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the albuterol sulfate profile page.
The generic ingredient in VOSPIRE ER is albuterol sulfate. There are thirty-eight drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the albuterol sulfate profile page.
Summary for 076130
| Tradename: | VOSPIRE ER |
| Applicant: | Strides Pharma |
| Ingredient: | albuterol sulfate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 4MG BASE | ||||
| Approval Date: | Sep 26, 2002 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 8MG BASE | ||||
| Approval Date: | Sep 26, 2002 | TE: | RLD: | No | |||||
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