Details for New Drug Application (NDA): 210409
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NDA 210409 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-two 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-two suppliers are listed for this compound. Additional details are available on the loratadine; pseudoephedrine sulfate profile page.
Summary for 210409
| Tradename: | LORATADINE |
| Applicant: | Hetero Labs Ltd Iii |
| Ingredient: | loratadine |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 210409
Suppliers and Packaging for NDA: 210409
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LORATADINE | loratadine | SYRUP;ORAL | 210409 | ANDA | Camber Consumer Care Inc | 69230-322 | 69230-322-12 | 1 BOTTLE in 1 CARTON (69230-322-12) / 120 mL in 1 BOTTLE |
| LORATADINE | loratadine | SYRUP;ORAL | 210409 | ANDA | Camber Consumer Care Inc | 69230-322 | 69230-322-24 | 1 BOTTLE in 1 CARTON (69230-322-24) / 240 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | SYRUP;ORAL | Strength | 1MG/ML | ||||
| Approval Date: | May 7, 2021 | TE: | RLD: | No | |||||
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