NDC 43598-097
JAVYGTOR
Sapropterin Dihydrochloride
JAVYGTOR is a Oral Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Dr. Reddys Laboratories Inc. The primary component is Sapropterin Dihydrochloride.
| Product ID | 43598-097_ecb86af2-3917-0f6e-b88c-b869f7350c0a |
| NDC | 43598-097 |
| Product Type | Human Prescription Drug |
| Proprietary Name | JAVYGTOR |
| Generic Name | Sapropterin Dihydrochloride |
| Dosage Form | Powder, For Solution |
| Route of Administration | ORAL |
| Marketing Start Date | 2022-09-16 |
| Marketing Category | ANDA / |
| Application Number | ANDA209452 |
| Labeler Name | Dr. Reddys Laboratories Inc |
| Substance Name | SAPROPTERIN DIHYDROCHLORIDE |
| Active Ingredient Strength | 100 mg/1 |
| Pharm Classes | Breast Cancer Resistance Protein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Phenylalanine Hydroxylase Activator [EPC], Phenylalanine Hydroxylase Activators [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
Packaging
NDC 43598-097-30
30 PACKET in 1 CARTON (43598-097-30) > 1 POWDER, FOR SOLUTION in 1 PACKET (43598-097-11)
| Marketing Start Date | 2022-09-16 |
| NDC Exclude Flag | N |
| Sample Package? | N |
Drug Details
NDC Crossover Matching brand name "JAVYGTOR" or generic name "Sapropterin Dihydrochloride"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 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 |
| 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 |
Trademark Results [JAVYGTOR]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 JAVYGTOR 97711360 not registered Live/Pending |
Cycle Pharmaceuticals Ltd. 2022-12-09 |
 JAVYGTOR 97434525 not registered Live/Pending |
Cycle Pharmaceuticals Ltd 2022-05-30 |
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