Details for New Drug Application (NDA): 203191
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NDA 203191 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, Anvi, Appco, Ascot, Chartwell Rx, Duramed Pharms Barr, Heritage Pharma, Ingenus Pharms Llc, Kenton, Kv Pharm, Md Pharm, Mountain, Mylan, 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 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 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 suppliers are listed for this compound. Additional details are available on the cyproheptadine hydrochloride profile page.
Summary for 203191
| Tradename: | CYPROHEPTADINE HYDROCHLORIDE |
| Applicant: | Chartwell Molecular |
| Ingredient: | cyproheptadine hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 203191
Suppliers and Packaging for NDA: 203191
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CYPROHEPTADINE HYDROCHLORIDE | cyproheptadine hydrochloride | SYRUP;ORAL | 203191 | ANDA | Chartwell RX, LLC | 62135-949 | 62135-949-47 | 473 mL in 1 BOTTLE (62135-949-47) |
| CYPROHEPTADINE HYDROCHLORIDE | cyproheptadine hydrochloride | SYRUP;ORAL | 203191 | ANDA | Chartwell RX, LLC | 62135-949 | 62135-949-94 | 946 mL in 1 BOTTLE (62135-949-94) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SYRUP;ORAL | Strength | 2MG/5ML | ||||
| Approval Date: | Jul 13, 2017 | TE: | AA | RLD: | No | ||||
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