Application 204438

Type: ANDA
Sponsor: PAR PHARM INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GLYCOPYRROLATE	GLYCOPYRROLATE	SOLUTION;ORAL	1MG/5ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A204438-001	GLYCOPYRROLATE	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA		2021-08-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A204438-001	AA

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A204438-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204438-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204438-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204438-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204438-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204438-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204438-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204438-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204438-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204438-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204438-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204438-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204438-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204438-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204438-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204438-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204438-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204438-001	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A204438-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204438-001	AA	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204438-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204438-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204438-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204438-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204438-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204438-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204438-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204438-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204438-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204438-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204438-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204438-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204438-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A204438-001	AA	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204438-001	PC	2022-07-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204438-001	PC	2022-07-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204438-001	PC	2022-07-03	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A204438-001	PC	2022-07-03	`bb7c543d1eb4…`
2023-01-26 05:58 UTC	2023-01	A204438-001	PC	2022-07-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204438-001	PC	2022-07-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204438-001	PC	2022-07-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204438-001	PC	2022-07-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204438-001	PC	2022-07-03	`cb3db0bc1861…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glycopyrrolate	GLYCOPYRROLATE	Par Health USA, LLC	ff65c5d3-7ba9-4315-a884-199151eb45a5	2026-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204438 application number: ANDA204438 ndc (product): 49884-042
Glycopyrrolate	GLYCOPYRROLATE	Precision Dose, Inc.	e58f860b-e955-4d71-a128-93bd3812b08d	2025-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204438 application number: ANDA204438
Glycopyrrolate	GLYCOPYRROLATE	Bryant Ranch Prepack	579d2499-6520-41fb-ae52-f3d8b9af8950	2024-01-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204438 application number: ANDA204438 ndc (product): 63629-9592

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49884-042	Glycopyrrolate	Glycopyrrolate	Par Pharmaceutical, Inc.	ANDA	Current
49884-042	Glycopyrrolate	Glycopyrrolate	Par Pharmaceutical, Inc.	ANDA	Current
49884-042	Glycopyrrolate	Glycopyrrolate	Par Pharmaceutical, Inc.	ANDA	Current
63629-9592	Glycopyrrolate	Glycopyrrolate	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
68519	ORIG	2021-09-02