Home Applications 079114 Application 079114
Type ANDA
Sponsor PERRIGO R AND D Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MICONAZOLE NITRATE MICONAZOLE NITRATE CREAM, SUPPOSITORY;TOPICAL, VAGINAL 2%,1.2GM No No 002 MICONAZOLE NITRATE MICONAZOLE NITRATE CREAM; TOPICAL, VAGINAL 2% Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A079114-001 MICONAZOLE NITRATE MICONAZOLE NITRATE 2%,1.2GM CREAM, INSERT / TOPICAL, VAGINAL 2010-06-02
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 2 of 2 · 44 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-10-28 04:53 UTC 2022-10 A079114-001 MICONAZOLE NITRATE 2%,1.2GM CREAM, INSERT / TOPICAL, VAGINAL 2010-06-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A079114-001 MICONAZOLE NITRATE 2%,1.2GM CREAM, INSERT / TOPICAL, VAGINAL 2010-06-02 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A079114-001 MICONAZOLE NITRATE 2%,1.2GM CREAM, INSERT / TOPICAL, VAGINAL 2010-06-02 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A079114-001 MICONAZOLE NITRATE 2%,1.2GM CREAM, INSERT / TOPICAL, VAGINAL 2010-06-02 a50c72e98297…
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 14 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 70 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0113-0916 good sense miconazole 1 Miconazole nitrate L. Perrigo Company ANDA Current 0113-7199 Basic Care miconazole 1 Miconazole nitrate L. Perrigo Company ANDA Current 0113-7199 Basic Care miconazole 1 Miconazole nitrate L. Perrigo Company ANDA Current 0113-9001 good sense miconazole 1 Miconazole nitrate L. Perrigo Company ANDA Current 0363-0199 Miconazole 1 Miconazole nitrate Walgreen Company ANDA Current 0363-0199 Miconazole 1 Miconazole nitrate Walgreen Company ANDA Current 0363-0737 Miconazole 1 Miconazole nitrate Walgreen Company ANDA Current 0363-0916 miconazole 1 Miconazole nitrate Walgreen Company ANDA Current 11673-199 up and up miconazole Miconazole nitrate Target Corporation ANDA Current 11673-199 up and up miconazole Miconazole nitrate Target Corporation ANDA Current 11673-199 up and up miconazole Miconazole nitrate Target Corporation ANDA Current 11673-199 up and up miconazole Miconazole nitrate Target Corporation ANDA Current 11673-737 Up and Up Miconazole 1 Miconazole nitrate Target Corporation ANDA Current 11822-0199 miconazole 1 Miconazole nitrate Rite Aid Corporation ANDA Current 11822-0737 miconazole 1 Miconazole nitrate Rite Aid Corporation ANDA Current 11822-0916 miconazole 1 Miconazole nitrate Rite Aid Corporation ANDA Current 11822-1104 miconazole 1 Miconazole nitrate Rite Aid Corporation ANDA Current 21130-040 Signature Care Miconazole 1 Miconazole nitrate Safeway ANDA Current 21130-040 Signature Care Miconazole 1 Miconazole nitrate Safeway ANDA Current 21130-040 Signature Care Miconazole 1 Miconazole nitrate Safeway ANDA Current 21130-737 Signature Care miconazole 1 Miconazole nitrate Safeway ANDA Current 30142-199 miconazole 1 Miconazole nitrate Kroger Company ANDA Current 30142-199 miconazole 1 Miconazole nitrate Kroger Company ANDA Current 30142-199 miconazole 1 Miconazole nitrate Kroger Company ANDA Current 30142-737 Miconazole 1 Miconazole nitrate Kroger Company ANDA Current 36800-199 topcare miconazole 1 Miconazole nitrate Topco Associates LLC ANDA Current 36800-199 topcare miconazole 1 Miconazole nitrate Topco Associates LLC ANDA Current 36800-199 topcare miconazole 1 Miconazole nitrate Topco Associates LLC ANDA Current 36800-199 topcare miconazole 1 Miconazole nitrate Topco Associates LLC ANDA Current 36800-199 topcare miconazole 1 Miconazole nitrate Topco Associates LLC ANDA Current 36800-737 topcare miconazole 1 Miconazole nitrate Topco Associates LLC ANDA Current 37808-199 miconazole 1 Miconazole nitrate H E B ANDA Current 37808-199 miconazole 1 Miconazole nitrate H E B ANDA Current 37808-199 miconazole 1 Miconazole nitrate H E B ANDA Current 37808-737 miconazole 1 Miconazole nitrate H E B ANDA Current 41250-199 miconazole 1 Miconazole nitrate Meijer Distribution Inc ANDA Current 41250-199 miconazole 1 Miconazole nitrate Meijer Distribution Inc ANDA Current 41250-199 miconazole 1 Miconazole nitrate Meijer Distribution Inc ANDA Current 41250-737 miconazole 1 Miconazole nitrate Meijer Distribution Inc ANDA Current 41520-616 careone miconazole 1 Miconazole nitrate American Sales Company ANDA Current 41520-616 careone miconazole 1 Miconazole nitrate American Sales Company ANDA Current 41520-916 care one miconazole 1 Miconazole nitrate American Sales Company ANDA Current 46122-577 Good Neighbor Pharmacy Miconazole 1 Miconazole nitrate Amerisource Bergen ANDA Current 46122-577 Good Neighbor Pharmacy Miconazole 1 Miconazole nitrate Amerisource Bergen ANDA Current 46122-577 Good Neighbor Pharmacy Miconazole 1 Miconazole nitrate Amerisource Bergen ANDA Current 49035-199 equate miconazole 1 Miconazole nitrate Wal-Mart Stores Inc ANDA Current 49035-199 equate miconazole 1 Miconazole nitrate Wal-Mart Stores Inc ANDA Current 49035-199 equate miconazole 1 Miconazole nitrate Wal-Mart Stores Inc ANDA Current 49035-199 equate miconazole 1 Miconazole nitrate Wal-Mart Stores Inc ANDA Current 49035-199 equate miconazole 1 Miconazole nitrate Wal-Mart Stores Inc ANDA Current 49035-737 Equate Miconazole 1 Miconazole nitrate Wal-Mart Stores Inc ANDA Current 49035-737 Equate Miconazole 1 Miconazole nitrate Wal-Mart Stores Inc ANDA Current 49738-003 image essentials miconazole treatment Miconazole nitrate Kmart Corporation ANDA Current 49738-199 Smart Sense miconazole 1 Miconazole nitrate Kmart Corporation ANDA Current 49738-403 Smart Sense Miconazole 1 Miconazole nitrate Kmart Corporation ANDA Current 49738-823 Smart Sense Miconazole 1 Miconazole nitrate Kmart Corporation ANDA Current 50066-199 lagicam Miconazole nitrate Genomma Lab USA, Inc. ANDA Current 50066-199 lagicam Miconazole nitrate Genomma Lab USA, Inc. ANDA Current 50066-811 lagicam Miconazole nitrate Genomma Lab USA, Inc. ANDA Current 55301-211 exchange select miconazole 1 Miconazole nitrate Army & Air Force Exchange Service ANDA Current 55301-211 exchange select miconazole 1 Miconazole nitrate Army & Air Force Exchange Service ANDA Current 55301-211 exchange select miconazole 1 Miconazole nitrate Army & Air Force Exchange Service ANDA Current 55301-916 Exchange Select Miconazole 1 Miconazole nitrate Army & Air Force Exchange Service ANDA Current 59779-199 miconazole 1 Miconazole nitrate CVS Pharmacy ANDA Current 59779-199 miconazole 1 Miconazole nitrate CVS Pharmacy ANDA Current 59779-199 miconazole 1 Miconazole nitrate CVS Pharmacy ANDA Current 59779-737 Miconazole 1 Miconazole nitrate CVS Pharmacy ANDA Current 70000-0315 Leader Miconazole 1 Miconazole nitrate Cardinal Health ANDA Current 72288-199 Basic Care Miconazole Miconazole nitrate Amazon.com Services LLC ANDA Current 72288-199 Basic Care Miconazole Miconazole nitrate Amazon.com Services LLC ANDA Current