Details for New Drug Application (NDA): 202168
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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 202168
Tradename: | ACYCLOVIR |
Applicant: | Cadila Pharms Ltd |
Ingredient: | acyclovir |
Patents: | 0 |
Pharmacology for NDA: 202168
Mechanism of Action | DNA Polymerase Inhibitors |
Medical Subject Heading (MeSH) Categories for 202168
Suppliers and Packaging for NDA: 202168
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ACYCLOVIR | acyclovir | TABLET;ORAL | 202168 | ANDA | Cadila Pharmaceuticals Limited | 71209-005 | 71209-005-05 | 100 TABLET in 1 BOTTLE (71209-005-05) |
ACYCLOVIR | acyclovir | TABLET;ORAL | 202168 | ANDA | Cadila Pharmaceuticals Limited | 71209-005 | 71209-005-10 | 500 TABLET in 1 BOTTLE (71209-005-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 400MG | ||||
Approval Date: | Nov 15, 2013 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 800MG | ||||
Approval Date: | Nov 15, 2013 | TE: | AB | RLD: | No |
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