Details for New Drug Application (NDA): 201445
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The generic ingredient in ACYCLOVIR is acyclovir sodium. There are fifty-six drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the acyclovir sodium profile page.
Summary for 201445
Tradename: | ACYCLOVIR |
Applicant: | Cadila Pharms Ltd |
Ingredient: | acyclovir |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 201445
Mechanism of Action | DNA Polymerase Inhibitors |
Medical Subject Heading (MeSH) Categories for 201445
Suppliers and Packaging for NDA: 201445
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ACYCLOVIR | acyclovir | CAPSULE;ORAL | 201445 | ANDA | NuCare Pharmaceuticals,Inc. | 68071-2235 | 68071-2235-5 | 5 CAPSULE in 1 BOTTLE (68071-2235-5) |
ACYCLOVIR | acyclovir | CAPSULE;ORAL | 201445 | ANDA | Cadila Pharmaceuticals Limited | 71209-004 | 71209-004-05 | 100 CAPSULE in 1 BOTTLE (71209-004-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 200MG | ||||
Approval Date: | Mar 6, 2014 | TE: | AB | RLD: | No |
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