Details for New Drug Application (NDA): 202520
NDA 202520 describes POLMON, which is a drug marketed by Pharmobedient and is included in one NDA. It is available from two suppliers. Additional details are available on the POLMON profile page.
The generic ingredient in POLMON is dexchlorpheniramine maleate. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the dexchlorpheniramine maleate profile page.
The generic ingredient in POLMON is dexchlorpheniramine maleate. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the dexchlorpheniramine maleate profile page.
Summary for 202520
| Tradename: | POLMON |
| Applicant: | Pharmobedient |
| 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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