Details for New Drug Application (NDA): 074738
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The generic ingredient in ACYCLOVIR is acyclovir sodium. There are fifty-six drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the acyclovir sodium profile page.
Summary for 074738
Tradename: | ACYCLOVIR |
Applicant: | Actavis Mid Atlantic |
Ingredient: | acyclovir |
Patents: | 0 |
Pharmacology for NDA: 074738
Mechanism of Action | DNA Polymerase Inhibitors |
Medical Subject Heading (MeSH) Categories for 074738
Suppliers and Packaging for NDA: 074738
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ACYCLOVIR | acyclovir | SUSPENSION;ORAL | 074738 | ANDA | Actavis Pharma, Inc. | 0472-0082 | 0472-0082-16 | 473 mL in 1 BOTTLE (0472-0082-16) |
ACYCLOVIR | acyclovir | SUSPENSION;ORAL | 074738 | ANDA | ATLANTIC BIOLOGICALS CORP. | 17856-0083 | 17856-0083-1 | 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0083-1) / 5 mL in 1 CUP, UNIT-DOSE (17856-0083-4) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 200MG/5ML | ||||
Approval Date: | Apr 28, 1997 | TE: | AB | RLD: | No |
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