Details for New Drug Application (NDA): 087400
✉ Email this page to a colleague
NDA 087400 describes THEOCHRON, which is a drug marketed by Nostrum Pharms Llc and is included in one NDA. It is available from one supplier. Additional details are available on the THEOCHRON profile page.
The generic ingredient in THEOCHRON is theophylline. There are thirty-six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the theophylline profile page.
The generic ingredient in THEOCHRON is theophylline. There are thirty-six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the theophylline profile page.
Summary for 087400
| Tradename: | THEOCHRON |
| Applicant: | Nostrum Pharms Llc |
| Ingredient: | theophylline |
| Patents: | 0 |
Suppliers and Packaging for NDA: 087400
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| THEOCHRON | theophylline | TABLET, EXTENDED RELEASE;ORAL | 087400 | ANDA | Nostrum Laboratories, Inc. | 29033-057 | 29033-057-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (29033-057-01) |
| THEOCHRON | theophylline | TABLET, EXTENDED RELEASE;ORAL | 087400 | ANDA | Nostrum Laboratories, Inc. | 29033-058 | 29033-058-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (29033-058-01) |
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 300MG | ||||
| Approval Date: | Jan 11, 1983 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 100MG | ||||
| Approval Date: | Feb 21, 1985 | TE: | RLD: | No | |||||
Profile for product number 004
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 200MG | ||||
| Approval Date: | Feb 21, 1985 | TE: | RLD: | No | |||||
Complete Access Available with Subscription
