Details for New Drug Application (NDA): 209108
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NDA 209108 describes CYPROHEPTADINE HYDROCHLORIDE, which is a drug marketed by Actavis Mid Atlantic, Chartwell Molecular, Elysium, Halsey, Morton Grove, Naska, Patrin, Pharm Assoc, Quagen, Rising, Tris Pharma Inc, Am Therap, Appco, Ascot, Beximco Pharms Usa, Chartwell Rx, Duramed Pharms Barr, Heritage Pharma, Kenton, Kv Pharm, Md Pharm, Mountain, Mylan, Novast Labs, Pioneer Pharms, Pliva, Strides Pharma, Superpharm, Vitarine, Watson Labs, and Zydus Pharms, and is included in thirty-nine NDAs. It is available from twenty-three 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-three 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-three suppliers are listed for this compound. Additional details are available on the cyproheptadine hydrochloride profile page.
Summary for 209108
| Tradename: | CYPROHEPTADINE HYDROCHLORIDE |
| Applicant: | Elysium |
| Ingredient: | cyproheptadine hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 209108
Suppliers and Packaging for NDA: 209108
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CYPROHEPTADINE HYDROCHLORIDE | cyproheptadine hydrochloride | SYRUP;ORAL | 209108 | ANDA | Patrin Pharma, Inc. | 39328-544 | 39328-544-16 | 473 mL in 1 BOTTLE, GLASS (39328-544-16) |
| CYPROHEPTADINE HYDROCHLORIDE | cyproheptadine hydrochloride | SYRUP;ORAL | 209108 | ANDA | Method Pharmaceuticals, LLC | 58657-697 | 58657-697-16 | 473 mL in 1 BOTTLE, GLASS (58657-697-16) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SYRUP;ORAL | Strength | 2MG/5ML | ||||
| Approval Date: | Oct 16, 2018 | TE: | AA | RLD: | No | ||||
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