FDA.reportPublic FDA data

Application 209312

Type
ANDA
Sponsor
GRANULES INDIA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METHOCARBAMOLMETHOCARBAMOLTABLET;ORAL500MGNoYes
002METHOCARBAMOLMETHOCARBAMOLTABLET;ORAL750MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
35573-413MethocarbamolMethocarbamolBurel Pharmaceuticals, Inc.ANDACurrent
35573-413MethocarbamolMethocarbamolBurel Pharmaceuticals, Inc.ANDACurrent
35573-413MethocarbamolMethocarbamolBurel Pharmaceuticals, Inc.ANDACurrent
35573-413MethocarbamolMethocarbamolBurel Pharmaceuticals, Inc.ANDACurrent
35573-414MethocarbamolMethocarbamolBurel Pharmaceuticals, Inc.ANDACurrent
35573-414MethocarbamolMethocarbamolBurel Pharmaceuticals, Inc.ANDACurrent
35573-414MethocarbamolMethocarbamolBurel Pharmaceuticals, Inc.ANDACurrent
35573-414MethocarbamolMethocarbamolBurel Pharmaceuticals, Inc.ANDACurrent
43063-903MethocarbamolMethocarbamol TabletsPD-Rx Pharmaceuticals, InANDACurrent
43063-903MethocarbamolMethocarbamol TabletsPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-903MethocarbamolMethocarbamol TabletsPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-903MethocarbamolMethocarbamol TabletsPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-903MethocarbamolMethocarbamol TabletsPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-903MethocarbamolMethocarbamol TabletsPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-903MethocarbamolMethocarbamol TabletsPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-905MethocarbamolMethocarbamol TabletsPD-Rx Pharmaceuticals, InANDACurrent
43063-905MethocarbamolMethocarbamol TabletsPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-905MethocarbamolMethocarbamol TabletsPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-905MethocarbamolMethocarbamol TabletsPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-905MethocarbamolMethocarbamol TabletsPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-905MethocarbamolMethocarbamol TabletsPD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-3556MethocarbamolMethocarbamol TabletsA-S Medication SolutionsANDACurrent
50090-3556MethocarbamolMethocarbamol TabletsA-S Medication SolutionsANDACurrent
50090-3556MethocarbamolMethocarbamol TabletsA-S Medication SolutionsANDACurrent
50090-3557MethocarbamolMethocarbamol TabletsA-S Medication SolutionsANDACurrent
50090-3557MethocarbamolMethocarbamol TabletsA-S Medication SolutionsANDACurrent
50090-3557MethocarbamolMethocarbamol TabletsA-S Medication SolutionsANDACurrent
50090-3570MethocarbamolMethocarbamol TabletsA-S Medication SolutionsANDACurrent
50090-3570MethocarbamolMethocarbamol TabletsA-S Medication SolutionsANDACurrent
50090-3570MethocarbamolMethocarbamol TabletsA-S Medication SolutionsANDACurrent
50436-0770MethocarbamolMethocarbamol TabletsUnit Dose ServicesANDACurrent
53002-3591MethocarbamolMethocarbamol TabletsRPK Pharmaceuticals, Inc.ANDACurrent
60760-770MethocarbamolMethocarbamol TabletsSt. Mary's Medical Park PharmacyANDACurrent
60760-770MethocarbamolMethocarbamol TabletsSt. Mary's Medical Park PharmacyANDACurrent
60760-770MethocarbamolMethocarbamol TabletsSt. Mary's Medical Park PharmacyANDACurrent
61919-610MethocarbamolMethocarbamolDirectRXANDACurrent
61919-610MethocarbamolMethocarbamolDirectRXANDACurrent
61919-610MethocarbamolMethocarbamolDirect_RxANDACurrent
61919-610MethocarbamolMethocarbamolDirect_RxANDACurrent
61919-610MethocarbamolMethocarbamolDirect_RxANDACurrent
61919-610MethocarbamolMethocarbamolDirect_RxANDACurrent
61919-610MethocarbamolMethocarbamolDirect_RxANDACurrent
61919-610MethocarbamolMethocarbamolDirect_RxANDACurrent
61919-616MethocarbamolMethocarbamolDIRECT RXANDACurrent
61919-616MethocarbamolMethocarbamolDirect_RxANDACurrent
61919-616MethocarbamolMethocarbamolDirect_RxANDACurrent
61919-616MethocarbamolMethocarbamolDirect_RxANDACurrent
61919-616MethocarbamolMethocarbamolDIRECT RXANDACurrent
61919-616MethocarbamolMethocarbamolDIRECT RXANDACurrent
61919-616MethocarbamolMethocarbamolDIRECT RXANDACurrent
61919-616MethocarbamolMethocarbamolDIRECT RXANDACurrent
61919-616MethocarbamolMethocarbamolDIRECT RXANDACurrent
61919-616MethocarbamolMethocarbamolDIRECT RXANDACurrent
61919-616MethocarbamolMethocarbamolDIRECT RXANDACurrent
61919-616MethocarbamolMethocarbamolDIRECT RXANDACurrent
62207-754MethocarbamolMethocarbamol TabletsGranules India LtdANDACurrent
62207-754MethocarbamolMethocarbamol TabletsGranules India LtdANDACurrent
62207-754MethocarbamolMethocarbamol TabletsGranules India LtdANDACurrent
62207-770MethocarbamolMethocarbamol TabletsGranules India LtdANDACurrent
62207-770MethocarbamolMethocarbamol TabletsGranules India LtdANDACurrent
62207-770MethocarbamolMethocarbamol TabletsGranules India LtdANDACurrent
63739-991MethocarbamolMethocarbamol TabletsMcKesson Corporation dba SKY PackagingANDACurrent
63739-992MethocarbamolMethocarbamol TabletsMcKesson Corporation dba SKY PackagingANDACurrent
67046-538MethocarbamolMethocarbamol TabletsContract Pharmacy Services-PAANDACurrent
68071-2867MethocarbamolMethocarbamol TabletsNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4505MethocarbamolMethocarbamol TabletsNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4505MethocarbamolMethocarbamol TabletsNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4505MethocarbamolMethocarbamol TabletsNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4505MethocarbamolMethocarbamol TabletsNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4520MethocarbamolMethocarbamol TabletsNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4520MethocarbamolMethocarbamol TabletsNuCare Pharmaceuticals,Inc.ANDACurrent
68788-8172MethocarbamolMethocarbamol TabletsPreferred Pharmaceuticals Inc.ANDACurrent
68788-8213MethocarbamolMethocarbamol TabletsPreferred Pharmaceuticals Inc.ANDACurrent
70010-754MethocarbamolMethocarbamol TabletsGranules Pharmaceuticals Inc.ANDACurrent
70010-754MethocarbamolMethocarbamol TabletsGranules Pharmaceuticals Inc.ANDACurrent
70010-754MethocarbamolMethocarbamol TabletsGranules Pharmaceuticals Inc.ANDACurrent
70010-770MethocarbamolMethocarbamol TabletsGranules Pharmaceuticals Inc.ANDACurrent
70010-770MethocarbamolMethocarbamol TabletsGranules Pharmaceuticals Inc.ANDACurrent
70010-770MethocarbamolMethocarbamol TabletsGranules Pharmaceuticals Inc.ANDACurrent
70518-1723MethocarbamolMethocarbamol TabletsREMEDYREPACK INC.ANDACurrent