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Details for New Drug Application (NDA): 090035

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NDA 090035 describes FOLIC ACID, which is a drug marketed by Hikma Pharms Llc, Ivax Sub Teva Pharms, Fresenius Kabi Usa, Valeant Pharm Intl, Jubilant Cadista, Nexgen Pharma Inc, Lannett, Nuvo Pharm Inc, Amneal Pharm, Mk Labs, Usl Pharma, Vangard, Tablicaps, Invagen Pharms, Lilly, Cadila Pharms Ltd, Watson Labs, Aiping Pharm Inc, Pioneer Pharms, Everylife, Vintage, Pharmeral, Contract Pharmacal, Ben Venue, Sandoz, Barr, Sun Pharm Inds, Purepac Pharm, Impax Labs, Whiteworth Town Plsn, Leading Pharma Llc, Vintage Pharms, Halsey, and UDL, and is included in thirty-six NDAs. It is available from thirty-seven suppliers. Additional details are available on the FOLIC ACID profile page.

The generic ingredient in FOLIC ACID is folic acid. There are eight drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the folic acid profile page.

Summary for NDA: 090035

Invagen Pharms
folic acid

Suppliers and Packaging for NDA: 090035

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
folic acid
TABLET;ORAL 090035 ANDA West-ward Pharmaceutical Corp 0143-9717 0143-9717-01 100 TABLET in 1 BOTTLE (0143-9717-01)
folic acid
TABLET;ORAL 090035 ANDA West-ward Pharmaceutical Corp 0143-9717 0143-9717-10 1000 TABLET in 1 BOTTLE (0143-9717-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Jun 9, 2009TE:AARLD:No

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