Details for New Drug Application (NDA): 202520
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NDA 202520 describes POLMON, which is a drug marketed by Capellon Pharms Llc and is included in one NDA. It is available from one supplier. Additional details are available on the POLMON profile page.
The generic ingredient in POLMON is dexchlorpheniramine maleate. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dexchlorpheniramine maleate profile page.
The generic ingredient in POLMON is dexchlorpheniramine maleate. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dexchlorpheniramine maleate profile page.
Summary for 202520
| Tradename: | POLMON |
| Applicant: | Capellon Pharms Llc |
| Ingredient: | dexchlorpheniramine maleate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 202520
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| POLMON | dexchlorpheniramine maleate | SYRUP;ORAL | 202520 | ANDA | CARWIN PHARMACEUTICAL ASSOCIATES, LLC | 15370-150 | 15370-150-04 | 118 mL in 1 BOTTLE, PLASTIC (15370-150-04) |
| POLMON | dexchlorpheniramine maleate | SYRUP;ORAL | 202520 | ANDA | CARWIN PHARMACEUTICAL ASSOCIATES, LLC | 15370-150 | 15370-150-16 | 473 mL in 1 BOTTLE, PLASTIC (15370-150-16) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SYRUP;ORAL | Strength | 2MG/5ML | ||||
| Approval Date: | Jul 16, 2018 | TE: | RLD: | No | |||||
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