BOSENTAN is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Cipla Usa Inc.. The primary component is Bosentan.
| Product ID | 69097-378_252ae260-45e5-4477-a702-830e83a16072 |
| NDC | 69097-378 |
| Product Type | Human Prescription Drug |
| Proprietary Name | BOSENTAN |
| Generic Name | Bosentan |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2020-01-03 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA210342 |
| Labeler Name | Cipla USA Inc. |
| Substance Name | BOSENTAN |
| Active Ingredient Strength | 125 mg/1 |
| Pharm Classes | Endothelin Receptor Antagonist [EPC],Endothelin Receptor Antagonists [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
| Marketing Start Date | 2020-01-03 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA210342 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2020-01-03 |
| Inactivation Date | 2020-01-31 |
| Reactivation Date | 2020-02-06 |
| Marketing Category | ANDA |
| Application Number | ANDA210342 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2020-01-03 |
| Inactivation Date | 2020-01-31 |
| Reactivation Date | 2020-02-06 |
| Ingredient | Strength |
|---|---|
| BOSENTAN | 125 mg/1 |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0054-0520 | Bosentan | Bosentan |
| 0054-0521 | Bosentan | Bosentan |
| 0591-2511 | bosentan | bosentan |
| 0591-2512 | bosentan | bosentan |
| 10148-125 | bosentan | bosentan |
| 10148-625 | bosentan | bosentan |
| 46708-383 | Bosentan | Bosentan |
| 46708-384 | Bosentan | Bosentan |
| 47335-038 | Bosentan | Bosentan |
| 47335-039 | Bosentan | Bosentan |
| 47781-270 | Bosentan | Bosentan |
| 47781-271 | Bosentan | Bosentan |
| 49884-058 | Bosentan | Bosentan |
| 49884-059 | Bosentan | Bosentan |
| 62332-383 | Bosentan | Bosentan |
| 62332-384 | Bosentan | Bosentan |
| 65162-873 | Bosentan | Bosentan |
| 65162-874 | Bosentan | Bosentan |
| 69097-377 | BOSENTAN | BOSENTAN |
| 69097-378 | BOSENTAN | BOSENTAN |
| 68382-446 | Bosentan | Bosentan |
| 68382-447 | Bosentan | Bosentan |
| 70771-1017 | Bosentan | Bosentan |
| 70771-1018 | Bosentan | Bosentan |
| 68180-387 | Bosentan | Bosentan |
| 68180-386 | Bosentan | Bosentan |
| 66215-101 | Tracleer | bosentan |