Details for New Drug Application (NDA): 215420
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NDA 215420 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 215420
| Tradename: | SAPROPTERIN DIHYDROCHLORIDE |
| Applicant: | Annora Pharma |
| Ingredient: | sapropterin dihydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 215420
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SAPROPTERIN DIHYDROCHLORIDE | sapropterin dihydrochloride | POWDER;ORAL | 215420 | ANDA | Camber Pharmaceuticals, Inc. | 31722-047 | 31722-047-30 | 30 PACKET in 1 CARTON (31722-047-30) / 1 POWDER, FOR SOLUTION in 1 PACKET (31722-047-01) |
| SAPROPTERIN DIHYDROCHLORIDE | sapropterin dihydrochloride | POWDER;ORAL | 215420 | ANDA | Camber Pharmaceuticals, Inc. | 31722-047 | 31722-047-31 | 1 PACKET in 1 CARTON (31722-047-31) / 1 POWDER, FOR SOLUTION in 1 PACKET (31722-047-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;ORAL | Strength | 100MG/PACKET | ||||
| Approval Date: | Aug 18, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;ORAL | Strength | 500MG/PACKET | ||||
| Approval Date: | Aug 18, 2022 | TE: | AB | RLD: | No | ||||
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