Details for New Drug Application (NDA): 040668
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NDA 040668 describes CYPROHEPTADINE HYDROCHLORIDE, which is a drug marketed by Actavis Mid Atlantic, Chartwell Molecular, Halsey, Morton Grove, Naska, Patrin, Pharm Assoc, Quagen, Rising, St John Pharm, Tris Pharma Inc, Am Therap, Appco, Ascot, Chartwell Rx, Duramed Pharms Barr, Heritage Pharma, Kenton, Kv Pharm, Md Pharm, Mountain, Mylan, Novast Labs, Pioneer Pharms, Pliva, Regcon Holdings, Strides Pharma Intl, Superpharm, Vitarine, Watson Labs, and Zydus Pharms, and is included in thirty-nine NDAs. It is available from twenty-one suppliers. Additional details are available on the CYPROHEPTADINE HYDROCHLORIDE profile page.
The generic ingredient in CYPROHEPTADINE HYDROCHLORIDE is cyproheptadine hydrochloride. There are six drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the cyproheptadine hydrochloride profile page.
The generic ingredient in CYPROHEPTADINE HYDROCHLORIDE is cyproheptadine hydrochloride. There are six drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the cyproheptadine hydrochloride profile page.
Summary for 040668
| Tradename: | CYPROHEPTADINE HYDROCHLORIDE |
| Applicant: | Rising |
| Ingredient: | cyproheptadine hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 040668
Suppliers and Packaging for NDA: 040668
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CYPROHEPTADINE HYDROCHLORIDE | cyproheptadine hydrochloride | SYRUP;ORAL | 040668 | ANDA | Rising Pharma Holdings, Inc. | 64980-504 | 64980-504-48 | 473 mL in 1 BOTTLE (64980-504-48) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SYRUP;ORAL | Strength | 2MG/5ML | ||||
| Approval Date: | Jun 28, 2006 | TE: | AA | RLD: | No | ||||
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