Details for New Drug Application (NDA): 091264
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NDA 091264 describes LEVOCETIRIZINE DIHYDROCHLORIDE, which is a drug marketed by Apotex, Chartwell Molecular, Padagis Us, Taro, Dr Reddys, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Granules, Hetero Labs Ltd Iii, Ipca Labs Ltd, Macleods Pharms Ltd, Micro Labs Ltd India, Perrigo R And D, Sankalp Lifecare, Sciegen Pharms Inc, Sun Pharm, Sun Pharm Inds Ltd, Synthon Bv, Teva Pharms, and Us Antibiotics, and is included in twenty-three NDAs. It is available from fifty-one suppliers. Additional details are available on the LEVOCETIRIZINE DIHYDROCHLORIDE profile page.
The generic ingredient in LEVOCETIRIZINE DIHYDROCHLORIDE is levocetirizine dihydrochloride. There are thirteen drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the levocetirizine dihydrochloride profile page.
The generic ingredient in LEVOCETIRIZINE DIHYDROCHLORIDE is levocetirizine dihydrochloride. There are thirteen drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the levocetirizine dihydrochloride profile page.
Summary for 091264
| Tradename: | LEVOCETIRIZINE DIHYDROCHLORIDE |
| Applicant: | Hetero Labs Ltd Iii |
| Ingredient: | levocetirizine dihydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 091264
| Mechanism of Action | Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 091264
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LEVOCETIRIZINE DIHYDROCHLORIDE | levocetirizine dihydrochloride | TABLET;ORAL | 091264 | ANDA | Camber Pharmaceuticals, Inc. | 31722-551 | 31722-551-05 | 500 TABLET in 1 BOTTLE (31722-551-05) |
| LEVOCETIRIZINE DIHYDROCHLORIDE | levocetirizine dihydrochloride | TABLET;ORAL | 091264 | ANDA | Camber Pharmaceuticals, Inc. | 31722-551 | 31722-551-10 | 1000 TABLET in 1 BOTTLE (31722-551-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Jun 29, 2012 | TE: | AB | RLD: | No | ||||
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