Details for New Drug Application (NDA): 087943
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NDA 087943 describes THEO-24, which is a drug marketed by Endo Operations and is included in one NDA. 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. Twenty-eight 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. Twenty-eight suppliers are listed for this compound. Additional details are available on the theophylline profile page.
Summary for 087943
| Tradename: | THEO-24 |
| Applicant: | Endo Operations |
| Ingredient: | theophylline |
| Patents: | 0 |
Suppliers and Packaging for NDA: 087943
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| THEO-24 | theophylline | CAPSULE, EXTENDED RELEASE;ORAL | 087943 | ANDA | ENDO USA, Inc. | 52244-200 | 52244-200-10 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (52244-200-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 200MG | ||||
| Approval Date: | Aug 22, 1983 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 100MG | ||||
| Approval Date: | Aug 22, 1983 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 300MG | ||||
| Approval Date: | Aug 22, 1983 | TE: | RLD: | No | |||||
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