Details for New Drug Application (NDA): 040560
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The generic ingredient in THEOPHYLLINE 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 040560
Tradename: | THEOPHYLLINE |
Applicant: | Nostrum Labs Inc |
Ingredient: | theophylline |
Patents: | 0 |
Suppliers and Packaging for NDA: 040560
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
THEOPHYLLINE | theophylline | TABLET, EXTENDED RELEASE;ORAL | 040560 | ANDA | Nostrum Laboratories, Inc. | 29033-001 | 29033-001-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (29033-001-01) |
THEOPHYLLINE | theophylline | TABLET, EXTENDED RELEASE;ORAL | 040560 | ANDA | Nostrum Laboratories, Inc. | 29033-002 | 29033-002-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (29033-002-01) |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 600MG | ||||
Approval Date: | Apr 21, 2006 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 400MG | ||||
Approval Date: | Apr 21, 2006 | TE: | AB | RLD: | No |
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