Details for New Drug Application (NDA): 085186
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NDA 085186 describes ELIXOPHYLLIN, which is a drug marketed by Forest Labs and Nostrum Labs Inc and is included in four NDAs. It is available from one supplier. Additional details are available on the ELIXOPHYLLIN profile page.
The generic ingredient in ELIXOPHYLLIN is theophylline. There are thirty-six drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the theophylline profile page.
The generic ingredient in ELIXOPHYLLIN is theophylline. There are thirty-six drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the theophylline profile page.
Summary for 085186
| Tradename: | ELIXOPHYLLIN |
| Applicant: | Nostrum Labs Inc |
| Ingredient: | theophylline |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 085186
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ELIXOPHYLLIN | theophylline | SOLUTION, ELIXIR;ORAL | 085186 | ANDA | Nostrum Laboratories, Inc. | 70408-644 | 70408-644-34 | 473 mL in 1 BOTTLE (70408-644-34) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION, ELIXIR;ORAL | Strength | 80MG/15ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AA | RLD: | Yes | ||||
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