Application 063067

Type
ANDA
Sponsor
CNTY LINE PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DYNACINMINOCYCLINE HYDROCHLORIDECAPSULE;ORALEQ 100MG BASENoNo
002DYNACINMINOCYCLINE HYDROCHLORIDECAPSULE;ORALEQ 75MG BASENoNo
003DYNACINMINOCYCLINE HYDROCHLORIDECAPSULE;ORALEQ 50MG BASENoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A063067-001DYNACINMINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORAL1990-07-31
A063067-002DYNACINMINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORAL1999-09-15
A063067-003DYNACINMINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORAL1990-08-14

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 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A063067-001DYNACINEQ 100MG BASECAPSULE / ORAL1990-07-3184e616aacf4f…
2026-09-14 22:38:342026-08A063067-002DYNACINEQ 75MG BASECAPSULE / ORAL1999-09-1584e616aacf4f…
2026-09-14 22:38:342026-08A063067-003DYNACINEQ 50MG BASECAPSULE / ORAL1990-08-1484e616aacf4f…
2026-08-18 06:07:402026-07A063067-001DYNACINEQ 100MG BASECAPSULE / ORAL1990-07-31caaa826d4ba7…
2026-08-18 06:07:402026-07A063067-002DYNACINEQ 75MG BASECAPSULE / ORAL1999-09-15caaa826d4ba7…
2026-08-18 06:07:402026-07A063067-003DYNACINEQ 50MG BASECAPSULE / ORAL1990-08-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A063067-001DYNACINEQ 100MG BASECAPSULE / ORAL1990-07-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A063067-002DYNACINEQ 75MG BASECAPSULE / ORAL1999-09-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A063067-003DYNACINEQ 50MG BASECAPSULE / ORAL1990-08-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A063067-001DYNACINEQ 100MG BASECAPSULE / ORAL1990-07-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A063067-002DYNACINEQ 75MG BASECAPSULE / ORAL1999-09-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A063067-003DYNACINEQ 50MG BASECAPSULE / ORAL1990-08-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A063067-001DYNACINEQ 100MG BASECAPSULE / ORAL1990-07-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A063067-002DYNACINEQ 75MG BASECAPSULE / ORAL1999-09-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A063067-003DYNACINEQ 50MG BASECAPSULE / ORAL1990-08-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A063067-001DYNACINEQ 100MG BASECAPSULE / ORAL1990-07-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A063067-002DYNACINEQ 75MG BASECAPSULE / ORAL1999-09-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A063067-003DYNACINEQ 50MG BASECAPSULE / ORAL1990-08-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A063067-001DYNACINEQ 100MG BASECAPSULE / ORAL1990-07-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A063067-002DYNACINEQ 75MG BASECAPSULE / ORAL1999-09-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A063067-003DYNACINEQ 50MG BASECAPSULE / ORAL1990-08-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A063067-001DYNACINEQ 100MG BASECAPSULE / ORAL1990-07-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A063067-002DYNACINEQ 75MG BASECAPSULE / ORAL1999-09-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A063067-003DYNACINEQ 50MG BASECAPSULE / ORAL1990-08-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A063067-001DYNACINEQ 100MG BASECAPSULE / ORAL1990-07-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A063067-002DYNACINEQ 75MG BASECAPSULE / ORAL1999-09-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A063067-003DYNACINEQ 50MG BASECAPSULE / ORAL1990-08-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A063067-001DYNACINEQ 100MG BASECAPSULE / ORAL1990-07-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A063067-002DYNACINEQ 75MG BASECAPSULE / ORAL1999-09-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A063067-003DYNACINEQ 50MG BASECAPSULE / ORAL1990-08-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A063067-001DYNACINEQ 100MG BASECAPSULE / ORAL1990-07-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A063067-002DYNACINEQ 75MG BASECAPSULE / ORAL1999-09-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A063067-003DYNACINEQ 50MG BASECAPSULE / ORAL1990-08-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A063067-001DYNACINEQ 100MG BASECAPSULE / ORAL1990-07-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A063067-002DYNACINEQ 75MG BASECAPSULE / ORAL1999-09-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A063067-003DYNACINEQ 50MG BASECAPSULE / ORAL1990-08-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A063067-001DYNACINEQ 100MG BASECAPSULE / ORAL1990-07-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A063067-002DYNACINEQ 75MG BASECAPSULE / ORAL1999-09-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A063067-003DYNACINEQ 50MG BASECAPSULE / ORAL1990-08-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A063067-001DYNACINEQ 100MG BASECAPSULE / ORAL1990-07-31301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 69 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A063067-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A063067-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A063067-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A063067-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A063067-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A063067-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A063067-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A063067-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A063067-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A063067-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A063067-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A063067-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A063067-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A063067-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A063067-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A063067-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A063067-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A063067-003AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A063067-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A063067-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A063067-003AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A063067-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A063067-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A063067-003AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A063067-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A063067-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A063067-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A063067-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A063067-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A063067-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A063067-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A063067-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A063067-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A063067-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A063067-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A063067-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A063067-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A063067-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A063067-003AB1ea99ee380514…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A063067-001AB1a72a2bbeb626…

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 2 of 4 · 71 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepack99825095-d897-4077-86df-483d505615b22026-03-25Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepack493bdeac-e073-4ec2-a481-85e6a6d3cb582026-03-25Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepack74946a91-b138-42cd-a9d4-58fe8f8492702026-03-25Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepack653b22f3-9eb5-4c29-9b95-bc1c4f0273be2026-03-25Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepacke1611d28-0c96-4ce2-ad5d-f62f66ec164d2026-03-25Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepackbb3b9a7e-6724-4c2a-b3cb-236f522b31a82026-03-09Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEA-S Medication Solutionsc96b1c5d-7004-4ee2-ad48-0ba963389f862026-02-19Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEREMEDYREPACK INC.6597bdc9-9e3a-4c11-8b39-27b47f8632872026-02-04Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline hydrochlorideMINOCYCLINE HYDROCHLORIDENorthwind Health Company, LLC0760232b-21a6-2b13-e063-6394a90a22c12026-01-01Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDENorthwind Health Company, LLC12559b29-6568-4b99-a16e-6a87038981f72026-01-01Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline hydrochlorideMINOCYCLINE HYDROCHLORIDENorthwind Health Company, LLCf33fcfd2-b9ef-8e67-e053-2a95a90a03062026-01-01Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEAscend Laboratories, LLCa8f95207-b259-4f50-87f2-3652d92688902025-12-18Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepack6b2a7493-2e6c-4901-b697-17eb188cc8dd2025-11-17Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
MinocinMINOCYCLINE HYDROCHLORIDEMelinta Therapeutics, LLCe415c323-8219-464b-9e3e-72c5a796cdaa2025-09-11Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepacke69284bc-0479-48d0-beb5-a26cfad6cd762025-08-25Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepack2688e63a-09c7-4d73-a923-cf14fec7b1a42025-07-28Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepackddd22f2c-050b-4776-912b-39b3e6202c752025-07-28Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEAmerican Health Packaging94d941e3-d3d8-4414-bd5c-4a92848e738f2025-07-25Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepack9f4139e4-d4ab-46ea-a3f1-f719ab57a55e2025-07-03Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepack084fb405-fcb9-4db9-8d95-5a9c1d89f3b62025-07-03Warnings, Adverse reactionsName fallback
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 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
47781-544minocycline hydrochlorideminocycline hydrochlorideAlvogen, Inc.ANDACurrent
47781-544minocycline hydrochlorideminocycline hydrochlorideAlvogen, Inc.ANDACurrent
47781-544minocycline hydrochlorideminocycline hydrochlorideAlvogen, Inc.ANDACurrent
47781-544minocycline hydrochlorideminocycline hydrochlorideAlvogen, Inc.ANDACurrent
47781-545minocycline hydrochlorideminocycline hydrochlorideAlvogen, Inc.ANDACurrent
47781-545minocycline hydrochlorideminocycline hydrochlorideAlvogen, Inc.ANDACurrent
47781-545minocycline hydrochlorideminocycline hydrochlorideAlvogen, Inc.ANDACurrent
47781-545minocycline hydrochlorideminocycline hydrochlorideAlvogen, Inc.ANDACurrent
47781-545minocycline hydrochlorideminocycline hydrochlorideAlvogen, Inc.ANDACurrent
47781-546minocycline hydrochlorideminocycline hydrochlorideAlvogen, Inc.ANDACurrent
47781-546minocycline hydrochlorideminocycline hydrochlorideAlvogen, Inc.ANDACurrent
47781-546minocycline hydrochlorideminocycline hydrochlorideAlvogen, Inc.ANDACurrent
47781-546minocycline hydrochlorideminocycline hydrochlorideAlvogen, Inc.ANDACurrent
47781-546minocycline hydrochlorideminocycline hydrochlorideAlvogen, Inc.ANDACurrent
50090-3644minocycline hydrochlorideminocycline hydrochlorideA-S Medication SolutionsANDACurrent
50090-3697minocycline hydrochlorideminocycline hydrochlorideA-S Medication SolutionsANDACurrent
50090-3697minocycline hydrochlorideminocycline hydrochlorideA-S Medication SolutionsANDACurrent
50090-3697minocycline hydrochlorideminocycline hydrochlorideA-S Medication SolutionsANDACurrent
50090-3697minocycline hydrochlorideminocycline hydrochlorideA-S Medication SolutionsANDACurrent
68071-5262minocycline hydrochlorideminocycline hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5262minocycline hydrochlorideminocycline hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
70934-775minocycline hydrochlorideminocycline hydrochlorideDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent