Details for New Drug Application (NDA): 211900
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NDA 211900 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 211900
| Tradename: | LORATADINE |
| Applicant: | Aurobindo Pharma |
| Ingredient: | loratadine |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 211900
Suppliers and Packaging for NDA: 211900
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LORATADINE | loratadine | CAPSULE;ORAL | 211900 | ANDA | Aurohealth LLC | 58602-818 | 58602-818-05 | 5 BLISTER PACK in 1 CARTON (58602-818-05) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK |
| LORATADINE | loratadine | CAPSULE;ORAL | 211900 | ANDA | Aurohealth LLC | 58602-818 | 58602-818-08 | 4 BLISTER PACK in 1 CARTON (58602-818-08) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 10MG | ||||
| Approval Date: | Mar 24, 2023 | TE: | RLD: | No | |||||
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