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Details for New Drug Application (NDA): 081034
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NDA 081034 describes THEO-24, which is a drug marketed by Actient Pharms, Auxilium Pharms Inc, and Auxilium Pharms Llc, and is included in four NDAs. It is available from one supplier. Additional details are available on the THEO-24 profile page.
The generic ingredient in THEO-24 is theophylline. There are thirty-six drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the theophylline profile page.
The generic ingredient in THEO-24 is theophylline. There are thirty-six drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the theophylline profile page.
Summary for 081034
| Tradename: | THEO-24 |
| Applicant: | Auxilium Pharms Inc |
| Ingredient: | theophylline |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 081034
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| THEO-24 | theophylline | CAPSULE, EXTENDED RELEASE;ORAL | 081034 | ANDA | Endo Pharmaceuticals, Inc. | 52244-400 | 52244-400-10 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (52244-400-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 400MG | ||||
| Approval Date: | Feb 28, 1992 | TE: | RLD: | No | |||||
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