Details for New Drug Application (NDA): 214806
✉ Email this page to a colleague
NDA 214806 describes THEOPHYLLINE, which is a drug marketed by Cent Pharms, Hospira, Inwood Labs, Sandoz, Kv Pharm, Scherer Rp, Alpharma Us Pharms, Cenci, Chartwell Rx, Halsey, Pharm Assoc, Precision Dose, Roxane, Taro, Wockhardt, Chartwell Molecular, Tris Pharma Inc, Able, Alembic, Amneal, Annora Pharma, Bionpharma, Glenmark Generics, Glenmark Pharms Ltd, Harman Finochem, Heritage Pharma Avet, Leading, Nostrum Labs Inc, Rhodes Pharms, Teva Pharms Inc, B Braun, Baxter Hlthcare, and Hospira Inc, and is included in fifty-one NDAs. It is available from nineteen suppliers. Additional details are available on the THEOPHYLLINE profile page.
The generic ingredient in THEOPHYLLINE 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 THEOPHYLLINE 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 214806
| Tradename: | THEOPHYLLINE |
| Applicant: | Harman Finochem |
| Ingredient: | theophylline |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 214806
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| THEOPHYLLINE | theophylline | TABLET, EXTENDED RELEASE;ORAL | 214806 | ANDA | Sun Pharmaceutical Industries Limited | 70095-017 | 70095-017-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70095-017-01) |
| THEOPHYLLINE | theophylline | TABLET, EXTENDED RELEASE;ORAL | 214806 | ANDA | Sun Pharmaceutical Industries Limited | 70095-018 | 70095-018-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70095-018-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 300MG | ||||
| Approval Date: | Oct 24, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 450MG | ||||
| Approval Date: | Oct 24, 2023 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
