Application 209274
- Type
- ANDA
- Sponsor
- GRANULES INDIA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0363-0606 | Wal-Zyr | Cetirizine HCl | Walgreens | ANDA | Current |
| 0363-0606 | Allergy Relief | Cetirizine HCl | Walgreens | ANDA | Current |
| 0363-0606 | Wal-Zyr | Cetirizine HCl | Walgreens | ANDA | Current |
| 0363-0606 | Wal-Zyr | Cetirizine HCl | Walgreens | ANDA | Current |
| 0363-0606 | Wal-Zyr | Cetirizine HCl | Walgreens | ANDA | Current |
| 0363-9899 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | WALGREEN CO. | ANDA | Current |
| 0363-9899 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | WALGREEN CO. | ANDA | Current |
| 0363-9899 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | WALGREEN CO. | ANDA | Current |
| 41163-197 | Allergy Relief | Cetirizine hydrochloride | UNFI | ANDA | Current |
| 47682-204 | Medique Cetiramed | Cetirizine HCl | Unifirst First Aid Corporation | ANDA | Current |
| 47682-204 | Medique Cetiramed | Cetirizine HCl | Unifirst First Aid Corporation | ANDA | Current |
| 47682-204 | Medique Cetiramed | Cetirizine HCl | Unifirst First Aid Corporation | ANDA | Current |
| 50066-396 | Allergy Relief | Cetirizine HCl 10 mg | Genomma Labs USA, Inc | ANDA | Current |
| 50066-396 | Allergy Relief | Cetirizine HCl 10 mg | Genomma Labs USA, Inc | ANDA | Current |
| 50090-3906 | Allergy Relief | Cetirizine HCl | A-S Medication Solutions | ANDA | Current |
| 50090-3906 | Allergy Relief | Cetirizine HCl | A-S Medication Solutions | ANDA | Current |
| 50090-3906 | Allergy Relief | Cetirizine HCl | A-S Medication Solutions | ANDA | Current |
| 51824-076 | CAREALL Cetirizine HCl | Cetirizine | New World Imports | ANDA | Current |
| 51824-076 | CAREALL Cetirizine HCl | Cetirizine | New World Imports | ANDA | Current |
| 53329-033 | Medline | cetirizine hcl | Medline Industries, Inc. | ANDA | Current |
| 53329-033 | Medline | cetirizine hcl | Medline Industries, Inc. | ANDA | Current |
| 53329-033 | Medline | cetirizine hcl | Medline Industries, Inc. | ANDA | Current |
| 53329-033 | Medline | cetirizine hcl | Medline Industries, LP | ANDA | Current |
| 53329-033 | Medline | cetirizine hcl | Medline Industries, LP | ANDA | Current |
| 53943-194 | ALLERGY RELIEF | Cetirizine hydrochloride | DISCOUNT DRUG MART | ANDA | Current |
| 54257-270 | Allergy Relief | CETIRIZINE HYDROCHLORIDE | Magno-Humphries, Inc. | ANDA | Current |
| 54257-270 | Allergy Relief | CETIRIZINE HYDROCHLORIDE | Magno-Humphries, Inc. | ANDA | Current |
| 54257-270 | Allergy Relief | CETIRIZINE HYDROCHLORIDE | Magno-Humphries, Inc. | ANDA | Current |
| 55315-806 | Allergy Relief | Cetirizine HCl | Freds Inc | ANDA | Current |
| 55315-806 | Allergy Relief | Cetirizine HCl | Freds Inc | ANDA | Current |
| 55315-806 | Allergy Relief | Cetirizine HCl | Freds Inc | ANDA | Current |
| 55681-302 | CETIRIZINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE | TWIN MED, LLC | ANDA | Current |
| 55681-302 | CETIRIZINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE | TWIN MED, LLC | ANDA | Current |
| 57344-194 | Allergy Relief | Cetirizine hydrochloride | AAA PHARMACEUTICAL, INC. | ANDA | Current |
| 57344-194 | Allergy Relief | Cetirizine hydrochloride | AAA PHARMACEUTICAL, INC. | ANDA | Current |
| 59726-806 | All Day Allergy Relief | Cetirizine HCl | P & L Development, LLC | ANDA | Current |
| 59726-806 | All Day Allergy Relief | Cetirizine HCl | P & L Development, LLC | ANDA | Current |
| 59726-806 | All Day Allergy Relief | Cetirizine HCl | P & L Development, LLC | ANDA | Current |
| 62011-0384 | All Day Allergy Relief | Cetirizine HCl | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0384 | All Day Allergy Relief | Cetirizine HCl | McKesson (Health Mart) | ANDA | Current |
| 62011-0384 | All Day Allergy Relief | Cetirizine HCl | Strategic Sourcing Services LLC | ANDA | Current |
| 62207-764 | Cetirizine hydrochloride | Cetirizine hydrochloride | Granules India Ltd | ANDA | Current |
| 62207-764 | Cetirizine hydrochloride | Cetirizine hydrochloride | Granules India Ltd | ANDA | Current |
| 62207-764 | Cetirizine hydrochloride | Cetirizine hydrochloride | Granules India Ltd | ANDA | Current |
| 62207-764 | Cetirizine hydrochloride | Cetirizine hydrochloride | Granules India Ltd | ANDA | Current |
| 63868-665 | Allergy Relief | Cetirizine hydrochloride | CHAIN DRUG MARKETING ASSOCIATION INC. | ANDA | Current |
| 63868-665 | Allergy Relief | Cetirizine hydrochloride | CHAIN DRUG MARKETING ASSOCIATION INC. | ANDA | Current |
| 63941-194 | Allergy Relief | Cetirizine hydrochloride | VALU MERCHANDISERS COMPANY | ANDA | Current |
| 66424-564 | CETIRIZINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE | SDA Laboratories, Inc. | ANDA | Current |
| 66715-6950 | 24 Hour Allergy | Cetirizine hydrochloride | Lil' Drug Store Products, Inc. | ANDA | Current |
| 66715-6950 | 24 Hour Allergy | Cetirizine hydrochloride | Lil' Drug Store Products, Inc. | ANDA | Current |
| 66715-6950 | 24 Hour Allergy | Cetirizine hydrochloride | Lil' Drug Store Products, Inc. | ANDA | Current |
| 67091-351 | Allergy Relief | Cetirizine HCl | WinCo Foods, LLC | ANDA | Current |
| 67091-351 | Allergy Relief | Cetirizine HCl | WinCo Foods, LLC | ANDA | Current |
| 68016-294 | Allergy Relief | Cetirizine hydrochloride | CHAIN DRUG CONSORTIUM | ANDA | Current |
| 68210-0119 | Cabinet Allergy Relief | Cetirizine Hydrochloride | Spirit Pharmaceutical LLC | ANDA | Current |
| 68210-0119 | CABINET Allergy Relief | Cetirizine Hydrochloride | Spirit Pharmaceutical LLC | ANDA | Current |
| 68210-0119 | CABINET Allergy Relief | Cetirizine Hydrochloride | Spirit Pharmaceutical LLC | ANDA | Current |
| 68210-0119 | CABINET Allergy Relief | Cetirizine Hydrochloride | Spirit Pharmaceutical LLC | ANDA | Current |
| 68210-4219 | Allergy Relief | Cetirizine Hydrochloride | Spirit Pharmaceutical LLC | ANDA | Current |
| 68210-4230 | Allergy Relief | Cetirizine Hydrochloride | Spirit Pharmaceutical LLC | ANDA | Current |
| 68998-194 | Allergy Relief | Cetirizine hydrochloride | MARC GLASSMAN, INC. | ANDA | Current |
| 68998-194 | Allergy Relief | Cetirizine hydrochloride | MARC GLASSMAN, INC. | ANDA | Current |
| 69168-396 | Allergy Relief | Cetirizine HCl 10 mg | Allegiant Health | ANDA | Current |
| 69168-396 | Allergy Relief | Cetirizine HCl 10 mg | Allegiant Health | ANDA | Current |
| 69230-304 | Allergy Relief | Cetirizine HCl | Camber Consumer Care | ANDA | Current |
| 69230-304 | Allergy Relief | Cetirizine HCl | Camber Consumer Care | ANDA | Current |
| 69230-304 | Allergy Relief | Cetirizine HCl | Camber Consumer Care | ANDA | Current |
| 69230-304 | Allergy Relief | Cetirizine HCl | Camber Consumer Care | ANDA | Current |
| 69230-304 | Allergy Relief | Cetirizine HCl | Camber Consumer Care | ANDA | Current |
| 69230-304 | Allergy Relief | Cetirizine HCl | Camber Consumer Care | ANDA | Current |
| 69230-304 | Allergy Relief | Cetirizine HCl | Camber Consumer Care | ANDA | Current |
| 69729-139 | Cetirizine hydrochloride | Cetirizine hydrochloride | OPMX LLC | ANDA | Current |
| 69729-139 | Cetirizine hydrochloride | Cetirizine hydrochloride | OPMX LLC | ANDA | Current |
| 69848-006 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Granules USA, Inc. | ANDA | Current |
| 70010-163 | Cetirizine hydrochloride | Cetirizine hydrochloride | Granules Pharmaceuticals Inc. | ANDA | Current |
| 70010-163 | Cetirizine hydrochloride | Cetirizine hydrochloride | Granules Pharmaceuticals Inc. | ANDA | Current |
| 70010-163 | Cetirizine hydrochloride | Cetirizine hydrochloride | Granules Pharmaceuticals Inc. | ANDA | Current |
| 70518-2731 | Allergy Relief | CETIRIZINE HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-2731 | Allergy Relief | CETIRIZINE HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |