Home Applications 050444 Application 050444
Type NDA
Sponsor REMPEX PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MINOCIN MINOCYCLINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 100MG BASE/VIAL Yes Yes
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 N050444-001 MINOCIN MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE/VIAL INJECTABLE / INJECTION RLD, RS, Approved before 1982
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N050444-001 12161656 2031-05-12 Drug product 2024-12-18 N050444-001 9084802 2031-05-12 U-282 2015-07-23 N050444-001 9278105 2031-05-12 U-282 2016-03-16 N050444-001 11944634 2032-10-16 Drug product 2024-04-02
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 N050444-001 MINOCIN EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N050444-001 MINOCIN EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050444-001 MINOCIN EQ 100MG BASE/VIAL INJECTABLE / INJECTION RLD, RS, Approved before 1982 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N050444-001 MINOCIN EQ 100MG BASE/VIAL INJECTABLE / INJECTION RLD, RS, Approved before 1982 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 3 · 116 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N050444-001 12161656 2031-05-12 Drug product 2024-12-18 c2088c7a36db…2026-10-15 13:18:30 2026-09 N050444-001 9084802 2031-05-12 U-282 2015-07-23 c2088c7a36db…2026-10-15 13:18:30 2026-09 N050444-001 9278105 2031-05-12 U-282 2016-03-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 N050444-001 11944634 2032-10-16 Drug product 2024-04-02 c2088c7a36db…2026-09-14 22:38:34 2026-08 N050444-001 12161656 2031-05-12 Drug product 2024-12-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N050444-001 9084802 2031-05-12 U-282 2015-07-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N050444-001 9278105 2031-05-12 U-282 2016-03-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N050444-001 11944634 2032-10-16 Drug product 2024-04-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 N050444-001 12161656 2031-05-12 Drug product 2024-12-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N050444-001 9084802 2031-05-12 U-282 2015-07-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N050444-001 9278105 2031-05-12 U-282 2016-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N050444-001 11944634 2032-10-16 Drug product 2024-04-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N050444-001 12161656 2031-05-12 Drug product 2024-12-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N050444-001 9084802 2031-05-12 U-282 2015-07-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N050444-001 9278105 2031-05-12 U-282 2016-03-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N050444-001 11944634 2032-10-16 Drug product 2024-04-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050444-001 12161656 2031-05-12 Drug product 2024-12-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050444-001 9084802 2031-05-12 U-282 2015-07-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050444-001 9278105 2031-05-12 U-282 2016-03-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050444-001 11944634 2032-10-16 Drug product 2024-04-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050444-001 12161656 2031-05-12 Drug product 2024-12-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N050444-001 9084802 2031-05-12 U-282 2015-07-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N050444-001 9278105 2031-05-12 U-282 2016-03-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N050444-001 11944634 2032-10-16 Drug product 2024-04-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050444-001 12161656 2031-05-12 Drug product 2024-12-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050444-001 9084802 2031-05-12 U-282 2015-07-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050444-001 9278105 2031-05-12 U-282 2016-03-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050444-001 11944634 2032-10-16 Drug product 2024-04-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050444-001 12161656 2031-05-12 Drug product 2024-12-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050444-001 9084802 2031-05-12 U-282 2015-07-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050444-001 9278105 2031-05-12 U-282 2016-03-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050444-001 11944634 2032-10-16 Drug product 2024-04-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050444-001 12161656 2031-05-12 Drug product 2024-12-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050444-001 9084802 2031-05-12 U-282 2015-07-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050444-001 9278105 2031-05-12 U-282 2016-03-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050444-001 11944634 2032-10-16 Drug product 2024-04-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050444-001 9084802 2031-05-12 U-282 2015-07-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050444-001 9278105 2031-05-12 U-282 2016-03-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050444-001 11944634 2032-10-16 Drug product 2024-04-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050444-001 9084802 2031-05-12 U-282 2015-07-23 5bbf6a4d5a75…
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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Minocin MINOCYCLINE HYDROCHLORIDE Melinta Therapeutics, LLC e415c323-8219-464b-9e3e-72c5a796cdaa 2025-09-11 Warnings, Adverse reactions Exact identifier application applno (NDA): 050444 application number: NDA050444 ndc (product): 70842-160
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 · 10 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 54531-100 Minocin minocycline hydrochloride Rempex Pharmaceuticals, Inc NDA Current 65293-014 Minocin minocycline hydrochloride The Medicines Company NDA Current 65293-014 Minocin minocycline hydrochloride The Medicines Company NDA Current 65293-014 Minocin minocycline hydrochloride The Medicines Company NDA Current 70842-160 Minocin minocycline hydrochloride Melinta Therapeutics, Inc NDA Current 70842-160 Minocin minocycline hydrochloride Melinta Therapeutics, Inc NDA Current 70842-160 Minocin minocycline hydrochloride Melinta Therapeutics, Inc NDA Current 70842-160 Minocin minocycline hydrochloride Melinta Therapeutics, LLC NDA Current 70842-160 Minocin minocycline hydrochloride Melinta Therapeutics, LLC NDA Current 70842-160 Minocin minocycline hydrochloride Melinta Therapeutics, LLC NDA Current