sapropterin dihydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Par Pharmaceutical, Inc.. The primary component is Sapropterin Dihydrochloride.
| Product ID | 49884-720_68401948-0a59-4c5b-9432-d85941ac41b0 |
| NDC | 49884-720 |
| Product Type | Human Prescription Drug |
| Proprietary Name | sapropterin dihydrochloride |
| Generic Name | Sapropterin Dihydrochloride |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2017-02-02 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA207200 |
| Labeler Name | Par Pharmaceutical, Inc. |
| Substance Name | SAPROPTERIN DIHYDROCHLORIDE |
| Active Ingredient Strength | 100 mg/1 |
| Pharm Classes | Phenylalanine Hydroxylase Activator [EPC],Phenylalanine Hydroxylase Activators [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2020-10-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA207200 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-02-02 |
| Marketing End Date | 2019-05-05 |
| Marketing Category | ANDA |
| Application Number | ANDA207200 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-02-02 |
| Marketing End Date | 2019-05-05 |
| Ingredient | Strength |
|---|---|
| SAPROPTERIN DIHYDROCHLORIDE | 100 mg/1 |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 31722-045 | sapropterin dihydrochloride | sapropterin dihydrochloride |
| 31722-047 | Sapropterin dihydrochloride | Sapropterin dihydrochloride |
| 31722-048 | Sapropterin dihydrochloride | Sapropterin dihydrochloride |
| 43598-162 | Sapropterin Dihydrochloride | Sapropterin Dihydrochloride |
| 43598-477 | Sapropterin Dihydrochloride | Sapropterin Dihydrochloride |
| 43598-749 | Sapropterin Dihydrochloride | Sapropterin Dihydrochloride |
| 49884-720 | sapropterin dihydrochloride | sapropterin dihydrochloride |
| 49884-873 | SAPROPTERIN DIHYDROCHLORIDE | SAPROPTERIN DIHYDROCHLORIDE |
| 49884-948 | SAPROPTERIN DIHYDROCHLORIDE | SAPROPTERIN DIHYDROCHLORIDE |
| 43598-096 | JAVYGTOR | Sapropterin Dihydrochloride |
| 43598-097 | JAVYGTOR | Sapropterin Dihydrochloride |
| 68135-300 | Kuvan | SAPROPTERIN DIHYDROCHLORIDE |
| 68135-301 | Kuvan | SAPROPTERIN DIHYDROCHLORIDE |
| 68135-482 | Kuvan | sapropterin dihydrochloride |