Details for New Drug Application (NDA): 215798
NDA 215798 describes SAPROPTERIN DIHYDROCHLORIDE, which is a drug marketed by Annora Pharma, Dr Reddys, Hopewell Pharma, Micro Labs, Ph Health, Aurobindo Pharma, and Hikma, and is included in twelve NDAs. It is available from eight suppliers. Additional details are available on the SAPROPTERIN DIHYDROCHLORIDE profile page.
The generic ingredient in SAPROPTERIN DIHYDROCHLORIDE is sapropterin dihydrochloride. There is one drug master file entry for this compound. Ten 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 is one drug master file entry for this compound. Ten suppliers are listed for this compound. Additional details are available on the sapropterin dihydrochloride profile page.
Summary for 215798
| Tradename: | SAPROPTERIN DIHYDROCHLORIDE |
| Applicant: | Dr Reddys |
| Ingredient: | sapropterin dihydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 215798
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SAPROPTERIN DIHYDROCHLORIDE | sapropterin dihydrochloride | FOR SOLUTION;ORAL | 215798 | ANDA | Dr. Reddys Laboratories Inc | 43598-162 | 43598-162-30 | 30 PACKET in 1 CARTON (43598-162-30) / 1 POWDER, FOR SOLUTION in 1 PACKET (43598-162-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;ORAL | Strength | 500MG/PACKET | ||||
| Approval Date: | May 13, 2022 | TE: | AB | RLD: | No | ||||
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