Details for New Drug Application (NDA): 087242
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NDA 087242 describes AMINOPHYLLINE, which is a drug marketed by Abraxis Pharm, Am Regent, Elkins Sinn, Hospira, Intl Medication, King Pharms, Luitpold, Lyphomed, Pharma Serve Ny, Smith And Nephew, Teva Parenteral, Morton Grove, Roxane, Impax Labs, Tablicaps, Vale, Ani Pharms, Ascot, Barr, Chartwell Molecular, Duramed Pharms Barr, Halsey, Hikma Intl Pharms, Kv Pharm, Pal Pak, Panray, Purepac Pharm, Valeant Pharm Intl, Vangard, Vintage Pharms, Watson Labs, and Actavis Mid Atlantic, and is included in fifty-eight NDAs. It is available from five suppliers. Additional details are available on the AMINOPHYLLINE profile page.
The generic ingredient in AMINOPHYLLINE is aminophylline. There are four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the aminophylline profile page.
The generic ingredient in AMINOPHYLLINE is aminophylline. There are four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the aminophylline profile page.
Summary for 087242
| Tradename: | AMINOPHYLLINE |
| Applicant: | Hospira |
| Ingredient: | aminophylline |
| Patents: | 0 |
Suppliers and Packaging for NDA: 087242
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMINOPHYLLINE | aminophylline | INJECTABLE;INJECTION | 087242 | ANDA | Henry Schein, Inc. | 0404-9813 | 0404-9813-10 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9813-10) / 10 mL in 1 VIAL, SINGLE-DOSE |
| AMINOPHYLLINE | aminophylline | INJECTABLE;INJECTION | 087242 | ANDA | Henry Schein, Inc. | 0404-9814 | 0404-9814-20 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9814-20) / 20 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 25MG/ML | ||||
| Approval Date: | Oct 26, 1983 | TE: | RLD: | Yes | |||||
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