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Details for New Drug Application (NDA): 081034
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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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