Tadalafil
- Product NDC
- 47335-011
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tadalafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA208934
- Marketing category
- ANDA
- Substance
- TADALAFIL
- Current FDA listing
- Yes
Related Records
Packages
| Package NDC | Description | Marketing start | Marketing end | Sample | Status |
|---|---|---|---|---|---|
| 47335-011-83 | 30 TABLET, FILM COATED in 1 BOTTLE (47335-011-83) | 2019-03-26 | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|---|---|---|---|
| These highlights do not include all the information needed to use TADALAFIL TABLETS safely and effectively. See full prescribing information for TADALAFIL TABLETS. TADALAFIL tablets, for oral use Initial U.S. Approval: 2003 | Bryant Ranch Prepack | 2024-04-03 | HUMAN PRESCRIPTION DRUG LABEL | 5 |
| These highlights do not include all the information needed to use TADALAFIL TABLETS safely and effectively. See full prescribing information for TADALAFIL TABLETS. TADALAFIL tablets, for oral use Initial U.S. Approval: 2003 | Sun Pharmaceutical Industries, Inc. | Sun Pharmaceutical Industries Limited | 2023-10-10 | Human Prescription Drug Label | 6 |