Details for New Drug Application (NDA): 207207
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NDA 207207 describes SAPROPTERIN DIHYDROCHLORIDE, which is a drug marketed by Annora Pharma, Dr Reddys, Hopewell Pharma, Ph Health, Aurobindo Pharma, and Zenara, and is included in eleven NDAs. It is available from seven suppliers. Additional details are available on the SAPROPTERIN DIHYDROCHLORIDE profile page.
The generic ingredient in SAPROPTERIN DIHYDROCHLORIDE is sapropterin dihydrochloride. There are three drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the sapropterin dihydrochloride profile page.
The generic ingredient in SAPROPTERIN DIHYDROCHLORIDE is sapropterin dihydrochloride. There are three drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the sapropterin dihydrochloride profile page.
Summary for 207207
| Tradename: | SAPROPTERIN DIHYDROCHLORIDE |
| Applicant: | Ph Health |
| Ingredient: | sapropterin dihydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 207207
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SAPROPTERIN DIHYDROCHLORIDE | sapropterin dihydrochloride | POWDER;ORAL | 207207 | ANDA | ENDO USA, Inc. | 49884-948 | 49884-948-72 | 30 PACKET in 1 CARTON (49884-948-72) / 1 POWDER, FOR SOLUTION in 1 PACKET (49884-948-52) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;ORAL | Strength | 100MG/PACKET | ||||
| Approval Date: | Aug 20, 2019 | TE: | AB | RLD: | No | ||||
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