Home Applications 214934 Application 214934
Type ANDA
Sponsor NEXUS PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 100MG BASE/VIAL No No
Source provenance: Browse the complete Orange Book source catalog .
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.
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 2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214934-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2024-10-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214934-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2024-10-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214934-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2024-10-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214934-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2024-10-24 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214934-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2024-10-24 d8e5a09893c0…2023-05-13 08:27 UTC 2023-05 A214934-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2022-07-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A214934-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2022-07-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A214934-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2022-07-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A214934-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2022-07-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A214934-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2022-07-22 e64feba35796…
Observed Orange Book normalized TE history# 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 4 of 4 · 71 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Arestin MINOCYCLINE HYDROCHLORIDE OraPharma, Inc. 8515df41-1936-4f3b-86ba-d2bb2a8441fb 2024-05-31 Warnings, Adverse reactions Name fallback generic name: MINOCYCLINE HYDROCHLORIDE Minocycline Hydrochloride MINOCYCLINE HYDROCHLORIDE Advanced Rx Pharmacy of Tennessee, LLC 192327c5-d2bc-1bd1-e063-6394a90a110b 2024-05-23 Warnings, Adverse reactions Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE Minocycline Hydrochloride MINOCYCLINE HYDROCHLORIDE Lupin Pharmaceuticals, Inc. 3b1e1cf1-ebd2-4aba-a219-9f9939fdb03b 2023-10-30 Warnings, Adverse reactions Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE Minocycline Hydrochloride MINOCYCLINE HYDROCHLORIDE A-S Medication Solutions 1229c84c-5627-4992-bb8a-7874b215c543 2023-09-17 Warnings, Adverse reactions Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE Minocycline Hydrochloride MINOCYCLINE HYDROCHLORIDE Proficient Rx LP 4f904969-5af3-461e-b557-d03a1e5c7292 2023-05-01 Warnings, Adverse reactions Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE Minocycline Hydrochloride MINOCYCLINE HYDROCHLORIDE Proficient Rx LP d5fcba91-6aa6-4072-aea5-fb8da65d9aac 2022-09-01 Warnings, Adverse reactions Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE Minocycline Hydrochloride MINOCYCLINE HYDROCHLORIDE Proficient Rx LP 49e65b60-ffc9-4ccd-9aec-29a462358d27 2022-05-01 Warnings, Adverse reactions Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE Minocycline Hydrochloride MINOCYCLINE HYDROCHLORIDE Strides Pharma Science Limited d6e136ba-c9b1-4846-ae2a-98a29cb4504d 2022-03-31 Warnings, Adverse reactions Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE Minocycline hydrochloride MINOCYCLINE HYDROCHLORIDE Proficient Rx LP e6b04358-0f4c-4b21-a7f3-320d1e7bc0b8 2021-01-01 Warnings, Adverse reactions Name fallback brand name: Minocycline hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE Minocycline Hydrochloride MINOCYCLINE HYDROCHLORIDE Proficient Rx LP d67e4b17-7d44-4d72-9150-420d98cc6db3 2019-11-01 Warnings, Adverse reactions Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE Minocycline Hydrochloride MINOCYCLINE HYDROCHLORIDE Bryant Ranch Prepack a84c29a9-21a8-4965-b5a5-37b28e4af5a0 2019-06-13 Warnings, Adverse reactions Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
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 · 1 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 14789-202 Minocycline Hydrochloride Minocycline Hydrochloride Nexus Pharmaceuticals Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 71957 ORIG 2022-08-30