Details for New Drug Application (NDA): 214280
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NDA 214280 describes LORATADINE, which is a drug marketed by Aurobindo Pharma, Bionpharma, Marksans Pharma, Strides Pharma, Taro, Aurobindo Pharma Ltd, Hetero Labs Ltd Iii, Lannett Co Inc, Perrigo, Pharm Assoc, Ranbaxy Labs Ltd, Teva, Wockhardt Bio Ag, Perrigo Pharma Intl, Sun Pharm, Actavis Labs Fl Inc, Glaxosmithkline, Rubicon, Tenshi, Anda Repository, Apotex Inc, Granules, Hetero Labs Ltd V, Mylan, Norvium Bioscience, Pld Acquisitions Llc, Sun Pharm Inds Ltd, Unique Pharm, Heritage Pharma, and P And L, and is included in forty-four NDAs. It is available from one hundred and fifty suppliers. Additional details are available on the LORATADINE profile page.
The generic ingredient in LORATADINE is loratadine; pseudoephedrine sulfate. There are thirty-nine drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the loratadine; pseudoephedrine sulfate profile page.
The generic ingredient in LORATADINE is loratadine; pseudoephedrine sulfate. There are thirty-nine drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the loratadine; pseudoephedrine sulfate profile page.
Summary for 214280
| Tradename: | LORATADINE |
| Applicant: | Rubicon |
| Ingredient: | loratadine |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 214280
Suppliers and Packaging for NDA: 214280
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LORATADINE | loratadine | TABLET, ORALLY DISINTEGRATING;ORAL | 214280 | ANDA | Advagen Pharma Limited | 72888-029 | 72888-029-09 | 1 BLISTER PACK in 1 CARTON (72888-029-09) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
| LORATADINE | loratadine | TABLET, ORALLY DISINTEGRATING;ORAL | 214280 | ANDA | Advagen Pharma Limited | 72888-029 | 72888-029-11 | 3 BLISTER PACK in 1 CARTON (72888-029-11) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 10MG | ||||
| Approval Date: | Sep 10, 2020 | TE: | RLD: | No | |||||
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